NCT02276339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

October 13, 2014

Last Update Submit

December 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    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

    Assessed at one time point only directly following the six-week intervention. Results presented 6 months later post analyses.

  • Range and speed of movement

    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)

    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.

Study Arms (1)

Single arm ankle exercise intervention

EXPERIMENTAL

Chronic Ankle Instability Group assessed pre and post a 6 week eccentric - concentric exercise intervention

Other: Exercise

Interventions

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.

Single arm ankle exercise intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's University Hospital

Dublin, Leinster, abc123, Ireland

Location

Related Publications (3)

  • 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.

    PMID: 16935061BACKGROUND
  • Gribble 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.

    PMID: 24377963BACKGROUND
  • Carcia 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.

    PMID: 18345343BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr. Ulrik McCarthy Persson, PhD

    University College Dublin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Sports Physiotherapy Masters programme UCD, Lecturer and Research supervisor

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations