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Effects of Gait Retraining With Auditory Feedback

Primary Purpose

Ankle Injuries, Ankle Inversion Sprain

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Auditory 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:

  • History of at least one ankle sprain
  • Index ankle sprain > 12 months prior to study enrollment
  • Most recent ankle sprain > 12 weeks prior to study enrollment
  • Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey.
  • Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales
  • Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.

Exclusion Criteria:

  • History of ankle surgery
  • History of other musculoskeletal injuries within the past 6 weeks
  • Any condition affecting plantar pressure distribution
  • Neurological or vestibular disorders affecting balance
  • Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function

Sites / Locations

  • UNC Charlotte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auditory Feedback

No Feedback

Arm Description

Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback.

Participants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback.

Outcomes

Primary Outcome Measures

Changes from baseline in lower extremity kinetics during walking
Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system
Changes from baseline in talar cartilage deformation before and after walking
Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging 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 static balance
Static balance will be measured via a force plate
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
Plantar pressure during forward lunges, lateral hops, and a step-down will be recorded with an in-shoe insole system.

Full Information

First Posted
March 4, 2020
Last Updated
November 1, 2022
Sponsor
University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT04302961
Brief Title
Effects of Gait Retraining With Auditory Feedback
Official Title
Effects of Gait Retraining With Auditory Feedback on Biomechanics and Ankle Joint Health in Individuals With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (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
There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.

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
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory Feedback
Arm Type
Experimental
Arm Description
Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback.
Arm Title
No Feedback
Arm Type
Active Comparator
Arm Description
Participants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback.
Intervention Type
Other
Intervention Name(s)
Auditory Feedback
Intervention Description
Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.
Intervention Type
Other
Intervention Name(s)
No Feedback
Intervention Description
Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.
Primary Outcome Measure Information:
Title
Changes from baseline in lower extremity kinetics during walking
Description
Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system
Time Frame
Immediate post-intervention, 1-week post-intervention
Title
Changes from baseline in talar cartilage deformation before and after walking
Description
Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system
Time Frame
Immediate post-intervention, 1-week 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-week post-intervention
Secondary Outcome Measure Information:
Title
Changes from baseline in static balance
Description
Static balance will be measured via a force plate
Time Frame
Immediate post-intervention, 1-week post-intervention
Title
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
Description
Plantar pressure during forward lunges, lateral hops, and a step-down will be recorded with an in-shoe insole system.
Time Frame
Immediate post-intervention, 1-week 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: History of at least one ankle sprain Index ankle sprain > 12 months prior to study enrollment Most recent ankle sprain > 12 weeks prior to study enrollment Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey. Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week. Exclusion Criteria: History of ankle surgery History of other musculoskeletal injuries within the past 6 weeks Any condition affecting plantar pressure distribution Neurological or vestibular disorders affecting balance 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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35504121
Citation
Torp DM, Thomas AC, Hubbard-Turner T, Donovan L. Plantar pressure profile during walking is associated with talar cartilage characteristics in individuals with chronic ankle instability. Clin Biomech (Bristol, Avon). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.
Results Reference
derived

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Effects of Gait Retraining With Auditory Feedback

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