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External Versus Internal Feedback in Patients With Chronic Ankle Instability

Primary Purpose

Ankle Injuries, Ankle Inversion Sprain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External focus of attention visual feedback
External focus of attention auditory feedback
Internal focus of attention video feedback
No feedback
Sponsored by
University of North Carolina, Charlotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC CharlotteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

ExFOCUS Visual

ExFOCUS Auditory

InFOCUS Visual

NoFeedback

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

Changes from baseline in ankle range of motion measured in degrees
Four different ankle ranges of motion will be measured
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.
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

Full Information

First Posted
October 16, 2019
Last Updated
June 7, 2023
Sponsor
University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT04131842
Brief Title
External Versus Internal Feedback in Patients With Chronic Ankle Instability
Official Title
External Versus Internal Feedback on Biomechanics and Self-reported Function in Patients With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Charlotte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Ankle Inversion Sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ExFOCUS Visual
Arm Type
Experimental
Arm Description
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.
Arm Title
ExFOCUS Auditory
Arm Type
Experimental
Arm Description
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.
Arm Title
InFOCUS Visual
Arm Type
Experimental
Arm Description
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.
Arm Title
NoFeedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
External focus of attention visual feedback
Intervention Description
Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.
Intervention Type
Other
Intervention Name(s)
External focus of attention auditory feedback
Intervention Description
Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.
Intervention Type
Other
Intervention Name(s)
Internal focus of attention video feedback
Intervention Description
Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.
Intervention Type
Other
Intervention Name(s)
No feedback
Intervention Description
Patients will receive no feedback during the impairment-based rehabilitation program.
Primary Outcome Measure Information:
Title
Changes from baseline in lower extremity kinematics and kinetics during walking
Description
Ankle, knee, and hip motion and moments during walking measured by a 3D motion capture system and in shoe plantar pressure system
Time Frame
Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Title
Changes from baseline in self-reported ankle function
Description
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).
Time Frame
Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary Outcome Measure Information:
Title
Changes from baseline in ankle range of motion measured in degrees
Description
Four different ankle ranges of motion will be measured
Time Frame
Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Title
Changes from baseline in ankle maximum voluntary isometric strength
Description
Ankle maximum voluntary isometric strength will be measured during four different ankle positions using a hand-held dynamometer.
Time Frame
Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Title
Changes from baseline in static and dynamic balance
Description
Static balance will be measured via a force plate and dynamic balance will be measured using the Star Excursion Balance Test
Time Frame
Immediate post-intervention, 1-month post-intervention, 3-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UNC Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Donovan, PhD
Phone
704-687-8611
Email
ldonova2@uncc.edu
First Name & Middle Initial & Last Name & Degree
Luke Donovan, PhD
First Name & Middle Initial & Last Name & Degree
Abbey Thomas, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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External Versus Internal Feedback in Patients With Chronic Ankle Instability

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