Ankle SprainNCT00601471
Effects of Proximal and Distal Tibiofibular Joint Manipulation on Lower Extremity Muscle Activation, Ankle Range of Motion, and Functional Outcome Scores in Individuals With Chronic Ankle Instability
A study testing proximal tibiofibular manipulation and distal tibiofibular manipulation in people with Ankle Sprain and Ankle Injuries, run by University of Virginia at 1 site in United States.
Trial summary
The overall aim of this project is to determine the effect of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles in individuals with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Sprain, Ankle Injuries, Sprain
- What is being tested?
- proximal tibiofibular manipulation and distal tibiofibular manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2010
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of more than one ankle sprain
- unilateral or bilateral
- Complaint of chronic ankle instability (CAI) and qualified according to
- 4 "YES" responses on the Ankle Instability Instrument (AII)
- Scoring at least an 85 on the Foot and Ankle Ability Measure (FAAM)
Who cannot join
- Lower extremity injury in the past 6 months (including lateral ankle sprain)
- Currently receiving physical therapy for a lower extremity injury
- Have a previous history of lower extremity surgery
- Have diagnosed ankle osteoarthritis or rheumatoid arthritis
- Currently pregnant or breast feeding
- History of connective tissue disorders (like Marfan's Syndrome or Ehlers Danlos Disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The overall aim of this project is to determine the effect of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles in individuals with chronic ankle instability. Another aim of this study is to determine the long term effects of a tibiofibular joint manipulation on range of motion and self-reported function.
We hypothesize that a manipulation applied at the distal tibiofibular joint will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores compared to a tibiofibular joint manipulation applied at the proximal joint. We further hypothesize that both distal and proximal tibiofibular joint manipulations will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores than no treatment at all.
Read the detailed description
Muscle weakness is a common impairment following injury to a joint. Individuals with lateral ankle sprains have been shown to demonstrate weakness and inhibition of the fibularis longus and soleus muscles. Recently, changes in the positional alignment of the talus, tibia, and fibula have been implicated in a subpopulation of individuals with chronic ankle instability (CAI). Clinically this manifests as a decrease in the posterior glide of the talus and decreased dorsiflexion ROM. Another positional fault has been noted to occur between the distal tibiofibular joint. A subpopulation of individuals with a history of CAI have demonstrated a slight anterior displacement of the fibula relative to the tibia. The cause of the malpositioning is unknown, but manual therapeutic interventions may offer the ability to restore normal joint arthrokinematics and muscle function. It is unknown if the correction of this positional fault will have an effect on muscle inhibition about the ankle.
Since muscle inhibition is a neurological reflexive reaction, it is thought that traditional strengthening treatment techniques may not fully address this dysfunction. Manual therapeutic interventions can have dual effects on the neuromuscular system and restore normal joint arthrokinematics. Evidence suggests a joint manipulation is able to disinhibit or even facilitate local and distant muscles. This likely occurs due to the afferent response from the structures in and around the manipulated joint. Comprehensive treatment interventions which restore normal joint function, optimal motoneuron pool excitability, strength, and pain-free previous level of function need to be developed to prevent future dysfunction and osteoarthritis.
Currently no study has examined the effects of tibiofibular joint manipulation on the neuromuscular response of ankle musculature or the effects on range of motion and function. The purpose of this study is to examine the acute effects of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles and to determine the long term effects on range of motion and function in individuals with CAI.
The first research question will address how a tibiofibular joint manipulation immediately affects the activation of the fibularis longus and soleus muscles. The second question will address how this joint manipulation affects range of motion and functional outcomes over a three week period. Changes in ankle dorsiflexion range of motion (ROM), navicular drop, Step Down Test, Balance Error Scoring System, and the Foot and Ankle Ability Measure (FAAM) will be used to determine if clinically significant changes occurred during the intervention period.
- Conditions
- Ankle Sprain, Ankle Injuries, Sprain
- Being tested
- proximal tibiofibular manipulation, distal tibiofibular manipulation, no intervention
- Keywords
- ankle sprain, ankle injuries, sprains and strains
- Medical subject headings
- Ankle Injuries, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal tibiofibular manipulationOther
proximal tibiofibular manipulation
distal tibiofibular manipulationOther
distal tibiofibular manipulation
no interventionOther
no intervention / control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | proximal tibiofibular manipulation Receives: Other: proximal tibiofibular manipulation |
| 2 | Experimental | distal tibiofibular manipulation Receives: Other: distal tibiofibular manipulation |
| 3 | No intervention | no treatment Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle activation
Measured: over a three week period
Secondary outcomes (2)
changes in functional range of motion
Measured: over a 3 week period
changes in function
Measured: over a three week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association
- Investigators
- Jay Hertel, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601471
- Sponsor's protocol ID
- 12966
- Status last verified
- Jun 2010
- First submitted
- 14 Jan 2008
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proximal and Distal Tibiofibular Joint Manipulation on Lower Extremity Muscle Activation, Ankle Range of Motion, and Functional Outcome Scores in Individuals With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT00601471
- Acronym / sponsor ID
- 12966
- Conditions
- Ankle Sprain, Ankle Injuries, Sprain
- Keywords
- ankle sprain, ankle injuries, sprains and strains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- Apr 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Jan 2008 (estimated)
- 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.
The overall aim of this project is to determine the effect of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles in individuals with chronic ankle instability. Another aim of this study is to determine the long term effects of a tibiofibular joint manipulation on range of motion and self-reported function.
We hypothesize that a manipulation applied at the distal tibiofibular joint will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores compared to a tibiofibular joint manipulation applied at the proximal joint. We further hypothesize that both distal and proximal tibiofibular joint manipulations will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores than no treatment at all.
Detailed description
Muscle weakness is a common impairment following injury to a joint. Individuals with lateral ankle sprains have been shown to demonstrate weakness and inhibition of the fibularis longus and soleus muscles. Recently, changes in the positional alignment of the talus, tibia, and fibula have been implicated in a subpopulation of individuals with chronic ankle instability (CAI). Clinically this manifests as a decrease in the posterior glide of the talus and decreased dorsiflexion ROM. Another positional fault has been noted to occur between the distal tibiofibular joint. A subpopulation of individuals with a history of CAI have demonstrated a slight anterior displacement of the fibula relative to the tibia. The cause of the malpositioning is unknown, but manual therapeutic interventions may offer the ability to restore normal joint arthrokinematics and muscle function. It is unknown if the correction of this positional fault will have an effect on muscle inhibition about the ankle.
Since muscle inhibition is a neurological reflexive reaction, it is thought that traditional strengthening treatment techniques may not fully address this dysfunction. Manual therapeutic interventions can have dual effects on the neuromuscular system and restore normal joint arthrokinematics. Evidence suggests a joint manipulation is able to disinhibit or even facilitate local and distant muscles. This likely occurs due to the afferent response from the structures in and around the manipulated joint. Comprehensive treatment interventions which restore normal joint function, optimal motoneuron pool excitability, strength, and pain-free previous level of function need to be developed to prevent future dysfunction and osteoarthritis.
Currently no study has examined the effects of tibiofibular joint manipulation on the neuromuscular response of ankle musculature or the effects on range of motion and function. The purpose of this study is to examine the acute effects of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles and to determine the long term effects on range of motion and function in individuals with CAI.
The first research question will address how a tibiofibular joint manipulation immediately affects the activation of the fibularis longus and soleus muscles. The second question will address how this joint manipulation affects range of motion and functional outcomes over a three week period. Changes in ankle dorsiflexion range of motion (ROM), navicular drop, Step Down Test, Balance Error Scoring System, and the Foot and Ankle Ability Measure (FAAM) will be used to determine if clinically significant changes occurred during the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: proximal tibiofibular manipulationproximal tibiofibular manipulation |
| 2 | Experimental | Other: distal tibiofibular manipulationdistal tibiofibular manipulation |
| 3 | No intervention | Other: no interventionno treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of more than one ankle sprain
- unilateral or bilateral
- Complaint of chronic ankle instability (CAI) and qualified according to
- 4 "YES" responses on the Ankle Instability Instrument (AII)
- Scoring at least an 85 on the Foot and Ankle Ability Measure (FAAM)
Key exclusion criteria (6 listed)
- Lower extremity injury in the past 6 months (including lateral ankle sprain)
- Currently receiving physical therapy for a lower extremity injury
- Have a previous history of lower extremity surgery
- Have diagnosed ankle osteoarthritis or rheumatoid arthritis
- Currently pregnant or breast feeding
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 |
|---|---|---|
| proximal tibiofibular manipulationproximal tibiofibular manipulation | Other | 1 |
| distal tibiofibular manipulationdistal tibiofibular manipulation | Other | 2 |
| no interventionno intervention / control | Other | 3 |
Primary outcome
Changes in muscle activation
Time frame: over a three week period
2 secondary outcomes
changes in functional range of motion
Time frame: over a 3 week period
changes in function
Time frame: over a three week period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2010.
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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.
Jay Hertel, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proximal tibiofibular manipulation and distal tibiofibular manipulation in people with Ankle Sprain and Ankle Injuries, run by University of Virginia 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 5 inclusion and 6 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 24 Jun 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in muscle activation (time frame: over a three week period). 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 24 Jun 2010.