Clinical trial NCT04302961: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ankle Injuries
Ankle Inversion Sprain
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from baseline in lower extremity kinetics during walking
timeFrame: Immediate post-intervention, 1-week post-intervention
measure: Changes from baseline in talar cartilage deformation before and after walking
timeFrame: Immediate post-intervention, 1-week post-intervention
measure: Changes from baseline in self-reported ankle function
timeFrame: Immediate post-intervention, 1-week post-intervention
Secondary outcomes:
measure: Changes from baseline in static balance
timeFrame: Immediate post-intervention, 1-week post-intervention
measure: 2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down
timeFrame: Immediate post-intervention, 1-week post-intervention
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: UNC Charlotte
state: North Carolina
Study officials:
References:
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). 2022 May;95:105656. doi: 10.1016/j.clinbiomech.2022.105656. Epub 2022 Apr 27.