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Muscle Activation in Chronic Ankle Instability and the Effect of an Exercise Programme

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ClinicalTrials.gov Identifier: NCT02276339
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Ulrik McCarthy Persson, University College Dublin

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ankle Injuries Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of the Peroneus Brevis and Peroneus Longus in Patients With Chronic Ankle Instability and the Effect of an Exercise Intervention
Study Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm ankle exercise intervention
Chronic Ankle Instability Group assessed pre and post a 6 week eccentric - concentric exercise intervention
Other: Exercise
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.

  3. 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. ]
    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.

  4. 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. ]
    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.

  5. 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. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276339


Locations
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Ireland
St. Vincent's University Hospital
Dublin, Leinster, Ireland, abc123
Sponsors and Collaborators
University College Dublin
Investigators
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Study Director: Dr. Ulrik McCarthy Persson, PhD University College Dublin
Publications:
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Responsible Party: Dr Ulrik McCarthy Persson, Director of Sports Physiotherapy Masters programme UCD, Lecturer and Research supervisor, University College Dublin
ClinicalTrials.gov Identifier: NCT02276339    
Other Study ID Numbers: LS-13-50-OShea-McCarthy
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries