Ankle InjuriesNCT02276339
Muscle Activation in Chronic Ankle Instability and the Effect of an Exercise Programme
A study testing Exercise in people with Ankle Injuries, run by University College Dublin at 1 site in Ireland.
Trial summary
This study aims to investigate the activity patterns of the peroneal muscle group, in individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared with individuals without ankle problems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2014to Dec 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The selection criteria for CAI patients will be based on the position statement of the International Ankle Consortium (2013).
- A history of at least 1 significant ankle sprain
- A history of the previously injured ankle joint "giving way", and/or recurrent sprain, and/or "feelings of instability". Self-reported ankle instability confirmed with validated ankle instability-specific questionnaire: The Cumberland Ankle Instability Tool. CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability (Hiller et al., 2006).
- A general self-reported foot and ankle function questionnaire is also completed. The Foot and Ankle Ability Measure: The FAAM is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle (Carcia et al., 2008).
Who cannot join
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity
- Any Neurological problem that would affect muscle function of the lower limb
- Pregnant Women
- Participants under 18 and over 65
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Peroneus Brevis and Peroneus Longus in Patients With Chronic Ankle Instability and the Effect of an Exercise Intervention
This study aims to investigate the activity patterns of the peroneal muscle group, in individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared with individuals without ankle problems. The study also aims to determine the effect of a targeted exercise programme on this muscle group in patients with CAI.
Research on this topic may provide important insight on the roles of these muscles in chronic ankle instability and investigate whether specific strengthening programmes are effective in this complex patient category.
Read the detailed description
The purpose of this study is to evaluate the role of the peroneus brevis (PB) and peroneus longus (PL) muscles in patients with chronic ankle instability and to determine whether an eccentric- concentric focused training intervention has an effect on these muscles.
Volunteers will be recruited from Orthopaedic Clinics and the Musculoskeletal Assessment Clinics in St. Vincent's University Hospital. Posters and information leaflets will be supplied to areas where volunteers are being sought. A study information sheet will be given to the patient and written consent will be obtained prior to commencing the investigative study.
Inclusion Criteria The selection criteria for chronic ankle instability (CAI) patients will be based on the position statement of the International Ankle Consortium (Gribble et al. 2013).
- A history of at least 1 significant ankle sprain
- A history of the previously injured ankle joint "giving way", and/or recurrent sprain, and/or "feelings of instability". Self-reported ankle instability confirmed with validated ankle instability-specific questionnaire: The Cumberland Ankle Instability Tool (CAIT). CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability.
- A general self-reported foot and ankle function questionnaire is also completed. The Foot and Ankle Ability Measure (FAAM): The FAAM is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle.
Exclusion Criteria
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity
- Any Neurological problem that would affect muscle function of the lower limb
- Pregnant Women
- Participants under 18 and over 65 Controls
- Healthy Volunteers (Control) will be age and sex matched to their CAI variants
- Will have no previous history of significant ankle sprain, which interrupted desired physical activity.
CAI patients will then be referred on for two radiological examinations in St. Vincent's
Hospital to aid diagnosis:
- A diagnostic ultrasound will be performed by Dr. Eric Heffernan to look at peroneal tendon pathology and ligament character (thickening and continuity).
- Stress Fluoroscopy (Anterior Drawer and Talar Tilt) will be performed by Professor Robert Flavin to assess for biplanar instability and to out rule subtalar instability.
Both participants with CAI and participants without ankle instability will undergo Surface electromyography (S-EMG) assessment of the PL, PB and Tibialis Anterior (TA) in both static and dynamic conditions in the University College Dublin School of Public Health, Physiotherapy \& Population science (SPHPPS) motion analysis laboratory (This assessment process will initially be piloted on a healthy volunteer) Muscle onset will be determined and S-EMG will also normalized to Max Voluntary Contraction (MVC) determining the magnitude of activation, during Single leg Stance, wobble-board standing, walking, calf-raise exercise, tip-toe walking, jogging and a jump-landing task.
Kinematic variables (degrees of movement and speed) will also be re-coded using CODA motion capture system during the movement tasks.
The participants will be performing the functional tests on a force platform to allow for assessment of kinetic variables measuring ground reaction force and measures of postural control.
Following S-EMG testing the CAI subjects will commence a six-week eccentric-concentric focused exercise programme.
The exercise intervention will consist of an individual home-based progressive eccentric-concentric strengthening programme. Patients will be reviewed every two weeks during their rehabilitation; exercises will be progressed accordingly by their physiotherapist.
Patients will be supplied with exercise diaries to assist with adherence to the exercise protocol.
At the end of the six-week programme they will undergo repeat S-EMG testing and complete the self-reported ankle questionnaires used at pre-test phase.
If using a power level of 80% and 5% significance, a sample size of 13 participants for each study group would be required for this study. To allow for a 23% dropout rate we will aim to recruit 16 patients to each group.
- Conditions
- Ankle Injuries
- Being tested
- Exercise
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercise intervention will consist of an individual home-based progressive eccentric-concentric strengthening programme. Patients will be reviewed every two weeks during their rehabilitation; exercises will be progressed accordingly by their physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Single arm ankle exercise intervention | Experimental | Chronic Ankle Instability Group assessed pre and post a 6 week eccentric - concentric exercise intervention Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface EMG
Both participants with CAI and participants without ankle instability will undergo S-EMG assessment of the peroneus longus, peroneus brevis and tibialis anterior in both static and dynamic conditions in a university motion analysis laboratory (This assessment process will initially be piloted on a healthy volunteer) Muscle onset will be determined and S-EMG will also normalised to Max Voluntary Contraction (MVC) determining the magnitude of activation, during Single leg Stance, wobble-board standing, Walking, Calf-raise exercise, Tip-toe walking, jogging and a jump-landing task. Change in EMG will be assessed at week 7 following the six-week intervention.
Measured: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in EMG following the six-week intervention. Results presented 6 months later post analyses.
Secondary outcomes (5)
The Cumberland Ankle Instability Tool (CAIT)
CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability (Hiller et al., 2006).Change in CAIT will be assessed at week 7 following the six-week intervention.
Measured: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in CAIT following the six-week intervention. Results presented 6 months later post analyses.
The Foot and Ankle Ability Measure (FAAM)
The FAAM is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle (Carcia et al., 2008).Change in FAAM will be assessed at week 7 following the six-week intervention.
Measured: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in FAAM following the six-week intervention. Results presented 6 months later post analyses.
Patient global impression of change (PGIC) scale
Global rating of change (GRC) scales are very commonly used in clinical research, particularly in the musculo-skeletal area. These scales are designed to quantify a patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. PGIC will only be assessed at one time point on week 7 following the six-week intervention.
Measured: Assessed at one time point only directly following the six-week intervention. Results presented 6 months later post analyses.
Range and speed of movement
Kinematic variables (degrees of movement and speed) will also be recorded using CODA motion capture system during the movement tasks. Change in range and speed movement will be assessed at week 7 following the six-week intervention.
Measured: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in movement following the six-week intervention. Results presented 6 months later post analyses.
Kinetic measures of ground reaction force (GRF)
The participants will be performing the functional tests on a force platform to allow for assessment of kinetic variables measuring ground reaction force and measures of postural control. Change in kinetic measures (GRF) will be assessed at week 7 following the six-week intervention.
Measured: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in GRF following the six-week intervention. Results presented 6 months later post analyses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ulrik McCarthy Persson, University College Dublin
- Investigators
- Dr. Ulrik McCarthy Persson, PhD, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276339
- Sponsor's protocol ID
- LS-13-50-OShea-McCarthy
- Status last verified
- Dec 2015
- First submitted
- 13 Oct 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
PubMed 16935061Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
PubMed 24377963Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
PubMed 18345343
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Peroneus Brevis and Peroneus Longus in Patients With Chronic Ankle Instability and the Effect of an Exercise Intervention
- ClinicalTrials.gov ID
- NCT02276339
- Acronym / sponsor ID
- LS-13-50-OShea-McCarthy
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Oct 2014 (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.
This study aims to investigate the activity patterns of the peroneal muscle group, in individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared with individuals without ankle problems. The study also aims to determine the effect of a targeted exercise programme on this muscle group in patients with CAI.
Research on this topic may provide important insight on the roles of these muscles in chronic ankle instability and investigate whether specific strengthening programmes are effective in this complex patient category.
Detailed description
The purpose of this study is to evaluate the role of the peroneus brevis (PB) and peroneus longus (PL) muscles in patients with chronic ankle instability and to determine whether an eccentric- concentric focused training intervention has an effect on these muscles.
Volunteers will be recruited from Orthopaedic Clinics and the Musculoskeletal Assessment Clinics in St. Vincent's University Hospital. Posters and information leaflets will be supplied to areas where volunteers are being sought. A study information sheet will be given to the patient and written consent will be obtained prior to commencing the investigative study.
Inclusion Criteria The selection criteria for chronic ankle instability (CAI) patients will be based on the position statement of the International Ankle Consortium (Gribble et al. 2013).
- A history of at least 1 significant ankle sprain
- A history of the previously injured ankle joint "giving way", and/or recurrent sprain, and/or "feelings of instability". Self-reported ankle instability confirmed with validated ankle instability-specific questionnaire: The Cumberland Ankle Instability Tool (CAIT). CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability.
- A general self-reported foot and ankle function questionnaire is also completed. The Foot and Ankle Ability Measure (FAAM): The FAAM is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle.
Exclusion Criteria
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity
- Any Neurological problem that would affect muscle function of the lower limb
- Pregnant Women
- Participants under 18 and over 65 Controls
- Healthy Volunteers (Control) will be age and sex matched to their CAI variants
- Will have no previous history of significant ankle sprain, which interrupted desired physical activity.
CAI patients will then be referred on for two radiological examinations in St. Vincent's
Hospital to aid diagnosis:
- A diagnostic ultrasound will be performed by Dr. Eric Heffernan to look at peroneal tendon pathology and ligament character (thickening and continuity).
- Stress Fluoroscopy (Anterior Drawer and Talar Tilt) will be performed by Professor Robert Flavin to assess for biplanar instability and to out rule subtalar instability.
Both participants with CAI and participants without ankle instability will undergo Surface electromyography (S-EMG) assessment of the PL, PB and Tibialis Anterior (TA) in both static and dynamic conditions in the University College Dublin School of Public Health, Physiotherapy \& Population science (SPHPPS) motion analysis laboratory (This assessment process will initially be piloted on a healthy volunteer) Muscle onset will be determined and S-EMG will also normalized to Max Voluntary Contraction (MVC) determining the magnitude of activation, during Single leg Stance, wobble-board standing, walking, calf-raise exercise, tip-toe walking, jogging and a jump-landing task.
Kinematic variables (degrees of movement and speed) will also be re-coded using CODA motion capture system during the movement tasks.
The participants will be performing the functional tests on a force platform to allow for assessment of kinetic variables measuring ground reaction force and measures of postural control.
Following S-EMG testing the CAI subjects will commence a six-week eccentric-concentric focused exercise programme.
The exercise intervention will consist of an individual home-based progressive eccentric-concentric strengthening programme. Patients will be reviewed every two weeks during their rehabilitation; exercises will be progressed accordingly by their physiotherapist.
Patients will be supplied with exercise diaries to assist with adherence to the exercise protocol.
At the end of the six-week programme they will undergo repeat S-EMG testing and complete the self-reported ankle questionnaires used at pre-test phase.
If using a power level of 80% and 5% significance, a sample size of 13 participants for each study group would be required for this study. To allow for a 23% dropout rate we will aim to recruit 16 patients to each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm ankle exercise intervention | Experimental | Other: ExerciseChronic Ankle Instability Group assessed pre and post a 6 week eccentric - concentric exercise intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The selection criteria for CAI patients will be based on the position statement of the International Ankle Consortium (2013).
- A history of at least 1 significant ankle sprain
- A history of the previously injured ankle joint "giving way", and/or recurrent sprain, and/or "feelings of instability". Self-reported ankle instability confirmed with validated ankle instability-specific questionnaire: The Cumberland Ankle Instability Tool. CAIT is a simple, valid, and reliable tool to measure severity of functional ankle instability (Hiller et al., 2006).
- A general self-reported foot and ankle function questionnaire is also completed. The Foot and Ankle Ability Measure: The FAAM is a reliable, responsive, and valid measure of physical function for individuals with a broad range of musculoskeletal disorders of the lower leg, foot, and ankle (Carcia et al., 2008).
Key exclusion criteria (4 listed)
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity
- Any Neurological problem that would affect muscle function of the lower limb
- Pregnant Women
- Participants under 18 and over 65
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 |
|---|---|---|
| ExerciseThe exercise intervention will consist of an individual home-based progressive eccentric-concentric strengthening programme. Patients will be reviewed every two weeks during their rehabilitation; exercises will be progressed accordingly by their physiotherapist. | Other | Single arm ankle exercise intervention |
Primary outcome
Surface EMG
Time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in EMG following the six-week intervention. Results presented 6 months later post analyses.
Both participants with CAI and participants without ankle instability will undergo S-EMG assessment of the peroneus longus, peroneus brevis and tibialis anterior in both static and dynamic conditions in a university motion analysis laboratory (This assessment process will initially be piloted on a healthy volunteer) Muscle onset will be determined and S-EMG will also normalised to Max Voluntary Contraction (MVC) determining the magnitude of activation, during Single leg Stance, wobble-board standing, Walking, Calf-raise exercise, Tip-toe walking, jogging and a jump-landing task. Change in EMG will be assessed at week 7 following the six-week intervention.
5 secondary outcomes
The Cumberland Ankle Instability Tool (CAIT)
Time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in CAIT following the six-week intervention. Results presented 6 months later post analyses.
The Foot and Ankle Ability Measure (FAAM)
Time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in FAAM following the six-week intervention. Results presented 6 months later post analyses.
Patient global impression of change (PGIC) scale
Time frame: Assessed at one time point only directly following the six-week intervention. Results presented 6 months later post analyses.
Range and speed of movement
Time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in movement following the six-week intervention. Results presented 6 months later post analyses.
Kinetic measures of ground reaction force (GRF)
Time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in GRF following the six-week intervention. Results presented 6 months later post analyses.
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 3 Dec 2015.
- Background: PubMed 16935061Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.
- Background: PubMed 24377963Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
- Background: PubMed 18345343Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
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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.
Dr. Ulrik McCarthy Persson, PhD study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Ankle Injuries, run by University College Dublin at 1 site in Ireland.
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 4 inclusion and 4 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 3 Dec 2015. 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 Ireland. 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?
Surface EMG (time frame: Assessed on day one, prior to intervention and at week 7 to assess change from baseline in EMG following the six-week intervention. Results presented 6 months later post analyses.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276339, which also lists 3 linked publications.
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 3 Dec 2015.