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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04131842
Other study ID # UNCCharlotte
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 18, 2020
Est. completion date June 17, 2024

Study information

Verified date June 2023
Source University of North Carolina, Charlotte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (CAI), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (PROs) are absent. Evidence suggests that external focus of attention (ExFOCUS), internal focus of attention (InFOCUS) feedback, and auditory feedback during movement training can alter biomechanics in other patient populations, with ExFOCUS and auditory enhancing retention of learned biomechanics. Therefore, this randomized controlled trial will determine if a 4-week (12 session) impairment-based rehabilitation program that includes feedback (ExFOCUS or InFOCUS or Auditory) can (1) decrease ankle inversion kinematics and lateral plantar pressure during walking and (2) improve self-reported function.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 17, 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Characterized as having chronic ankle instability (CAI) by reporting a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. Participants will have lingering symptoms, and disability, but have not actively sought treatment for their CAI. - All participants will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week. Exclusion Criteria: - Neurological or vestibular disorders affecting balance - Currently seeking medical care for CAI - History of ankle surgery - History of ankle sprain within the past 6 weeks - History of other musculoskeletal injuries within the past 6 weeks - Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function

Study Design


Related Conditions & MeSH terms


Intervention

Other:
External focus of attention visual feedback
Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.
External focus of attention auditory feedback
Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.
Internal focus of attention video feedback
Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.
No feedback
Patients will receive no feedback during the impairment-based rehabilitation program.

Locations

Country Name City State
United States UNC Charlotte Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in lower extremity kinematics and kinetics during walking Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Primary Changes from baseline in self-reported ankle function Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function). Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary Changes from baseline in ankle range of motion measured in degrees Four different ankle ranges of motion will be measured Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary Changes from baseline in ankle maximum voluntary isometric strength Ankle maximum voluntary isometric strength will be measured during four different ankle positions using a hand-held dynamometer. Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary Changes from baseline in static and dynamic balance Static balance will be measured via a force plate and dynamic balance will be measured using the Star Excursion Balance Test Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
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