External Versus Internal Feedback in Patients With Chronic Ankle Instability

NCT04131842 | Completed

• 1 other identifier: IRBIS-19-0263
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Injuries; Ankle Inversion Sprain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Changes from baseline in ankle range of motion measured in degrees

  Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

• Changes from baseline in ankle maximum voluntary isometric strength

  Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

• Changes from baseline in static and dynamic balance

  Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

Study Arms (4)

ExFOCUS Visual

EXPERIMENTAL

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive external focus of attention visual feedback.

Other: External focus of attention visual feedback

ExFOCUS Auditory

EXPERIMENTAL

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive auditory feedback.

Other: External focus of attention auditory feedback

InFOCUS Visual

EXPERIMENTAL

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and will receive internal focus of attention visual feedback via video.

Other: Internal focus of attention video feedback

NoFeedback

ACTIVE COMPARATOR

Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools and receive no feedback.

Other: No feedback

Interventions

External focus of attention visual feedback OTHER

Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.

ExFOCUS Visual

External focus of attention auditory feedback OTHER

Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.

ExFOCUS Auditory

Internal focus of attention video feedback OTHER

Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.

InFOCUS Visual

No feedback OTHER

Patients will receive no feedback during the impairment-based rehabilitation program.

NoFeedback

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Charlotte: lead

Study Sites (1)

UNC Charlotte

Charlotte, North Carolina, 28223, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: February 18, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)