Ankle Inversion SprainNCT03418051
Mechanisms of Manual Therapies in CAI Patients
A study testing Joint Mobilization and Massage in people with Ankle Inversion Sprain and Chronic Instability of Joint, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
ABSTRACT: Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Inversion Sprain, Chronic Instability of Joint
- What is being tested?
- Joint Mobilization and Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with Chronic Ankle Instability which will be defined as those individuals who:
- have sustained at least two lateral ankle sprains;
- have experienced at least one episode of giving way within the past 6-months;
- answer 4 or more questions of "yes" on the Ankle Instability Instrument;
- have self-assessed disability scores of ≤90% on the Foot and Ankle Ability Measure;
- have self-assessed disability scores ≤80% on the Foot and Ankle Ability Measure-Sport.
Show all 20Show fewer
- Exclusion criteria for Chronic Ankle Instability will include:
- known vestibular and vision problems,
- acute lower extremities and head injuries (<6 weeks),
- chronic musculoskeletal conditions known to affect balance (e.g., Anterior Cruciate Ligament deficiency) and
- a history of ankle surgeries to fix internal derangement.
- Participants will also be excluded if they have any of the following which are contraindications to Transcranial Magnetic Stimulation testing:
- metal anywhere in the head (except in the mouth),
- pacemakers,
- implantable medical pumps,
- ventriculo-peritoneal shunts,
- intracardiac lines,
- history of seizures,
- history of stroke
- history of serious head trauma.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Mechanisms of Manual Therapies in Chronic Ankle Instability Patients
ABSTRACT:
Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.
- Being tested
- Joint Mobilization, Massage
- Keywords
- Ankle Instability, Manual Therapy, Massage, Ankle Joint Mobilization, Biomechanics, Neuromuscular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint MobilizationOther
Also called Ankle Joint Mobilization
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
MassageOther
Also called Plantar Massage
Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group that will receive no intervention throughout the duration of the study (2-weeks). |
| Joint Mobilization | Experimental | Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. Receives: Other: Joint Mobilization |
| Massage | Experimental | Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
ML COP Velocity From Baseline to Post Intervention
% Modulation of ML COP velocity.
First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
ML COP Velocity From Baseline to Follow-Up
% Modulation of ML COP velocity.
First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the Follow-Up assessment.
Measured: Baseline and 4-week Follow-Up
AP COP Velocity From Baseline to Post Intervention
% Modulation of AP COP velocity.
First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
AP COP Velocity From Baseline to Follow-up
% Modulation of AP COP velocity.
First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
ML TTB From Baseline to Post Intervention
% Modulation of ML Time-to-Boundary.
First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
Measured: Baseline and 24-72 hours post intervention
ML TTB From Baseline to Follow-Up
% Modulation of ML Time-to-Boundary.
First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
Measured: Baseline and 4-week Follow-Up
AP TTB From Baseline to Post Intervention
% Modulation of AP Time-to-Boundary.
First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
Measured: Baseline and 24-72 hours post intervention
AP TTB From Baseline to Follow-Up
% Modulation of AP Time-to-Boundary.
First, time-to-Boundary is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
Measured: Baseline and 4-week Follow-Up
95% Confidence Ellipse From Baseline to Post Intervention
% Modulation of 95% Confidence Ellipse.
First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
95% Confidence Ellipse From Baseline to Follow-Up
% Modulation of 95% Confidence Ellipse.
First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial.
Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 4-week Follow-Up
Secondary outcomes (24)
Plantar Flexion Joint Position Sense From Baseline to Post Intervention
Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Plantar Flexion Joint Position Sense From Baseline to Follow-Up
Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
1st Metatarsal Light-touch Threshold From Baseline to Post Intervention
Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. his analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
1st Metatarsal Light-touch Threshold From Baseline to Follow-Up
Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
5th Metatarsal Light-touch Threshold From Baseline to Post Intervention
Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
5th Metatarsal Light-touch Threshold From Baseline to Follow-Up
Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow Up
Soleus H:M Ratio From Baseline to Post Intervention
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.
The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Measured: Baseline and 24-72 hours post intervention
Soleus H:M Ratio From Baseline to Follow-Up
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.
The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Measured: Baseline and 4-week Follow-Up
Fibularis Longus H:M Ratio From Baseline to Post Intervention
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.
The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Measured: Baseline and 24-72 hours post intervention
Fibularis Longus H:M Ratio From Baseline to Follow-Up
This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment.
The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
Measured: Baseline and 4-week Follow-Up
Fibularis Longus Active Motor Threshold From Baseline to Post Intervention
A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Fibularis Longus Active Motor Threshold From Baseline to Follow-Up
A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 4-week Follow-Up
Cortical Silent Period From Baseline to Post Intervention
A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Cortical Silent Period From Baseline to Follow-Up
A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
Corticomotor Map Area From Baseline to Post Intervention
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Corticomotor Map Area From Baseline to Follow-Up
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
Corticomotor Map Volume From Baseline to Post Intervention
A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Corticomotor Map Volume From Baseline to Follow-Up
measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 4-week Follow-Up
Alpha Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Alpha Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate follow-up assessment.
Measured: Baseline and 4-week Follow-Up
Beta Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Beta Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
Gamma Power Spectral Density From Baseline to Post Intervention
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
Measured: Baseline and 24-72 hours post intervention
Gamma Power Spectral Density From Baseline to Follow-Up
A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the follow-up assessment.
Measured: Baseline and 4-week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Sep 2018
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle Inversion SprainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Erik Wikstrom, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418051
- Sponsor's protocol ID
- 17-2655
- Other IDs
- 1R21AT009704-01
- Status last verified
- Jul 2021
- First submitted
- 24 Jan 2018
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The entire dataset will link the outcomes and demographics but will be devoid of patient identifying information. Upon completion of the study, this information will be available to those who request the data, meet the access criteria, and agree to a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Mechanisms of Manual Therapies in Chronic Ankle Instability Patients
- ClinicalTrials.gov ID
- NCT03418051
- Acronym / sponsor ID
- 17-2655
- Keywords
- Ankle Instability, Manual Therapy, Massage, Ankle Joint Mobilization, Biomechanics, Neuromuscular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ABSTRACT:
Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group that will receive no intervention throughout the duration of the study (2-weeks). |
| Joint Mobilization | Experimental | Other: Joint MobilizationParticipants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. |
| Massage | Experimental | Other: MassageParticipants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Individuals with Chronic Ankle Instability which will be defined as those individuals who:
- have sustained at least two lateral ankle sprains;
- have experienced at least one episode of giving way within the past 6-months;
- answer 4 or more questions of "yes" on the Ankle Instability Instrument;
- have self-assessed disability scores of ≤90% on the Foot and Ankle Ability Measure;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint MobilizationAlso: Ankle Joint MobilizationParticipants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion. | Other | Joint Mobilization |
| MassageAlso: Plantar MassageParticipants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface. | Other | Massage |
Primary outcome
ML COP Velocity From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
ML COP Velocity From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
% Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the Follow-Up assessment.
AP COP Velocity From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
AP COP Velocity From Baseline to Follow-up
Time frame: Baseline and 4-week Follow-Up
% Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the follow-up assessment.
ML TTB From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
ML TTB From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
% Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
AP TTB From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
% Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
AP TTB From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
% Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
95% Confidence Ellipse From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
95% Confidence Ellipse From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
% Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
24 secondary outcomes
Plantar Flexion Joint Position Sense From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Plantar Flexion Joint Position Sense From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
1st Metatarsal Light-touch Threshold From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
1st Metatarsal Light-touch Threshold From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
5th Metatarsal Light-touch Threshold From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
5th Metatarsal Light-touch Threshold From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow Up
Soleus H:M Ratio From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Soleus H:M Ratio From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Fibularis Longus H:M Ratio From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Fibularis Longus H:M Ratio From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Fibularis Longus Active Motor Threshold From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Fibularis Longus Active Motor Threshold From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Cortical Silent Period From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Cortical Silent Period From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Corticomotor Map Area From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Corticomotor Map Area From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Corticomotor Map Volume From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Corticomotor Map Volume From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Alpha Power Spectral Density From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Alpha Power Spectral Density From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Beta Power Spectral Density From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Beta Power Spectral Density From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Gamma Power Spectral Density From Baseline to Post Intervention
Time frame: Baseline and 24-72 hours post intervention
Gamma Power Spectral Density From Baseline to Follow-Up
Time frame: Baseline and 4-week Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The entire dataset will link the outcomes and demographics but will be devoid of patient identifying information. Upon completion of the study, this information will be available to those who request the data, meet the access criteria, and agree to a data use agreement.
Related trials for Ankle Inversion Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries
Ankle Sprains
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Wikstrom, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Mobilization and Massage in people with Ankle Inversion Sprain and Chronic Instability of Joint, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ML COP Velocity From Baseline to Post Intervention (time frame: Baseline and 24-72 hours post intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.