External Versus Internal Feedback in Patients With Chronic Ankle Instability

Not Applicable

Completed

• Conditions: Ankle Injuries; Ankle Inversion Sprain

• Registration Number: NCT04131842
• Lead Sponsor: University of North Carolina, Charlotte

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2020-02-18
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from baseline in lower extremity kinematics and kinetics during walking	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention	Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system
Changes from baseline in self-reported ankle function	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention	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).

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in ankle range of motion measured in degrees	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention	Four different ankle ranges of motion will be measured
Changes from baseline in ankle maximum voluntary isometric strength	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention	Ankle maximum voluntary isometric strength will be measured during four different ankle positions using a hand-held dynamometer.
Changes from baseline in static and dynamic balance	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention	Static balance will be measured via a force plate and dynamic balance will be measured using the Star Excursion Balance Test

Trial Locations

Locations (1)

UNC Charlotte; 🇺🇸 Charlotte, North Carolina, United States