Joint InstabilityESCAIPNCT04314960
Functional Electrical Stimulation in Chronic Ankle Instability
A study testing Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA) in people with Joint Instability and Ankle Sprains, run by Shmuel Springer at 1 site in Israel.
Trial summary
Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Instability, Ankle Sprains, Sport Injury
- What is being tested?
- Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jun 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A history of at least one significant ankle sprain:
- At least 12 months prior to participating in the study
- Was characterized by inflammatory symptoms (i.e. pain and swelling)
- Caused at least one day of decreased physical activity
- At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.
- History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.
- Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
- Scoring<24 in the Cumberland Ankle Instability Tool (CAIT)
Who cannot join
- A history of previous surgeries to a musculoskeletal structure in either lower limb.
- A history of a fracture requiring re-alignment
- Any acute injury to a lower limb in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ariel University
Ariel, 40700
Uri Gottlieb, 0542022767, urigott@gmail.com
About this study
Official title: Immediate and Long-term Effects of Gait Training With Functional Electrical Stimulation in Subjects With Chronic Ankle Instability
Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may overcome inhibition, and which is coupled with a functional task such as gait.
The current study aims to investigate the short and immediate effects of FES on gait parameters and postural control in subjects with CAI. Prior to intervention, treadmill gait will be evaluated using a motion analysis system, and postural control will be evaluated in a series of tests that measure balance, reaction time to ankle perturbation and stabilization ability after jump-landing. Then, a 20 minutes gait training with an FES device will be applied. Immediate effects of the training on gait parameters will be assessed. For medium-term effects evaluation, subjects will return for additional 7 training sessions (2 per week for 4 weeks), following by a complete measurements acquisition as prior to intervention. At six months follow-up, subjects will be contacted for collecting subjective outcomes.
- Conditions
- Joint Instability, Ankle Sprains, Sport Injury
- Being tested
- Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)
- Keywords
- Chronic ankle instability, Rehabilitation, Neuromuscular control, Gait, Electrical stimulation
- Medical subject headings
- Joint Instability, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)Device
Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| CAI subjects | Experimental | Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation. Receives: Device: Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in ankle inversion angle during heel strike
Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system.
Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.
Measured: immediately after the intervention
Change in ankle inversion angle during heel strike at 4 weeks
Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system.
Change will be measured between pre-intervention and after completing the entire intervention.
Measured: through intervention completion, approximately at 4 weeks
Immediate change in peroneal muscle electromyography
Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike.
Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.
Measured: immediately after the intervention
Change in peroneal muscle electromyography at 4 weeks
Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike.
Change will be measured between pre-intervention and after completing the entire intervention.
Measured: through intervention completion, approximately at 4 weeks
Secondary outcomes (3)
Change in Star excursion balance test (SEBT) score
The SEBT has been previously described as a postural control test that can differ between subjects with CAI and healthy controls. The test is performed with the subjects standing barefoot in the middle of a grid formed by eight tape measures extending out at 45° from each other. While the subject is balancing on one leg that is placed in the middle of the grid, the other leg has to reach as far as possible in each direction. The reached distance in centimeters is recorded, with the greater distance representing better postural stability. An average scores is calculated and normalized to the length of the subject's leg in centimeters.
Measured: through intervention completion, approximately at 4 weeks
Time to stabilization (TTS)
TTS is the time required to normalize ground reaction forces (GRF) after following a jump-landing. To measure TTS, subjects will be required to perform a single-leg drop-jump from a 40-cm box onto a force plate (Kistler, Switzerland) and keep balancing on a single leg for 20 seconds. GRF recordings will be analyzed to determine TTS in seconds in the ML and AP planes, as was previously described. Shorter duration demonstrates better postural stability. Subjects will be allowed at least 3 practice trials, following by 5 successful jumps landings. A rest period of 30 seconds will be allowed between jumps. If a subject will not be able to stabilize for at least 20 seconds, the trial will be repeated.
Lower values indicate better postural control.
Measured: through intervention completion, approximately at 4 weeks
Peroneal reaction time (PRT)
PRT is the time duration between and ankle inversion perturbation and beginning of peroneal muscle activation which is recognized using EMG. Subjects will stand on an inversion stimulator. In an unknown time, a sudden inversion perturbation will occur. Time measurement between perturbation time and muscle activation time is measured in seconds.
Lower values indicate better postural control.
Measured: through intervention completion, approximately at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start23 Jun 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InstabilityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shmuel Springer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shmuel Springer, Ariel University
- Investigators
- Shmuel Springer, PhD, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314960
- Sponsor's protocol ID
- AU-HEA-SS-20200308a
- Acronym
- ESCAIP
- Status last verified
- Sep 2020
- First submitted
- 15 Mar 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not decided yet, but optional to share all data after concealing subject's identifying details.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Long-term Effects of Gait Training With Functional Electrical Stimulation in Subjects With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04314960
- Acronym / sponsor ID
- ESCAIP / AU-HEA-SS-20200308a
- Conditions
- Joint Instability, Ankle Sprains, Sport Injury
- Keywords
- Chronic ankle instability, Rehabilitation, Neuromuscular control, Gait, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Shmuel SpringerUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with chronic ankle instability (CAI) display neuromuscular deficits such as altered control of posture and gait when compared with healthy controls. These deficits may be attributed to muscle inhibition occurring after a surrounding joint structure has been damaged. Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may overcome inhibition, and which is coupled with a functional task such as gait.
The current study aims to investigate the short and immediate effects of FES on gait parameters and postural control in subjects with CAI. Prior to intervention, treadmill gait will be evaluated using a motion analysis system, and postural control will be evaluated in a series of tests that measure balance, reaction time to ankle perturbation and stabilization ability after jump-landing. Then, a 20 minutes gait training with an FES device will be applied. Immediate effects of the training on gait parameters will be assessed. For medium-term effects evaluation, subjects will return for additional 7 training sessions (2 per week for 4 weeks), following by a complete measurements acquisition as prior to intervention. At six months follow-up, subjects will be contacted for collecting subjective outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAI subjects | Experimental | Device: Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)Subjects in this group will receive eight 20-minutes gait training sessions with functional electrical stimulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- A history of at least one significant ankle sprain:
- At least 3 months since the last acute ankle sprain that results in inflammatory symptoms and at least one interrupted day of desired physical activity.
- History of the previously injured ankle 'giving way' at least twice during the last 6 months, and/or 'feelings of instability' and/or recurrent sprain.
- Being able to bear full weight on the injured lower extremity with no more than mild discomfort.
- Scoring<24 in the Cumberland Ankle Instability Tool (CAIT)
Key exclusion criteria (3 listed)
- A history of previous surgeries to a musculoskeletal structure in either lower limb.
- A history of a fracture requiring re-alignment
- Any acute injury to a lower limb in the last 3 months.
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 |
|---|---|---|
| Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill. | Device | CAI subjects |
Primary outcome
Immediate change in ankle inversion angle during heel strike
Time frame: immediately after the intervention
Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.
Change in ankle inversion angle during heel strike at 4 weeks
Time frame: through intervention completion, approximately at 4 weeks
Ankle inversion angle at heel strike (in degrees) will be measured using Qualisys motion analysis system. Change will be measured between pre-intervention and after completing the entire intervention.
Immediate change in peroneal muscle electromyography
Time frame: immediately after the intervention
Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention to immediately after first intervention session to assess immediate effects of the intervention.
Change in peroneal muscle electromyography at 4 weeks
Time frame: through intervention completion, approximately at 4 weeks
Peroneal muscle activity will be measured (in millivolts) using Trigno EMG system during the 5% of gait cycle prior to heel strike. Change will be measured between pre-intervention and after completing the entire intervention.
3 secondary outcomes
Change in Star excursion balance test (SEBT) score
Time frame: through intervention completion, approximately at 4 weeks
Time to stabilization (TTS)
Time frame: through intervention completion, approximately at 4 weeks
Peroneal reaction time (PRT)
Time frame: through intervention completion, approximately at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No. Not decided yet, but optional to share all data after concealing subject's identifying details.
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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.
Shmuel Springer, PhD principal investigator
Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA) in people with Joint Instability and Ankle Sprains, run by Shmuel Springer at 1 site in Israel.
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Gottlieb, MSc (+972542022767, urigott@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate change in ankle inversion angle during heel strike (time frame: immediately after the intervention). The study lists 4 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 2 Sep 2020.