Effects of Gait Retraining With Auditory Feedback
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Oct 2020
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 19, 2024
August 1, 2024
9 months
March 4, 2020
August 16, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Changes from baseline in lower extremity kinetics during walking
Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system
Immediate post-intervention, 1-week post-intervention
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
Immediate post-intervention, 1-week 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-week post-intervention
Secondary Outcomes (2)
Changes from baseline in static balance
Immediate post-intervention, 1-week post-intervention
2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
Immediate post-intervention, 1-week post-intervention
Study Arms (2)
Auditory Feedback
EXPERIMENTALParticipants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving auditory feedback.
No Feedback
ACTIVE COMPARATORParticipants will complete 8 sessions over a 2-week period of walking on a treadmill without receiving feedback.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Charlotte
Charlotte, North Carolina, 28223, United States
Related Publications (1)
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). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.
PMID: 35504121DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 10, 2020
Study Start
October 5, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share