Clinical trial NCT04131842: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries
Ankle Inversion Sprain
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 48
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: 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.


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

Primary outcomes:
measure: Changes from baseline in lower extremity kinematics and kinetics during walking
timeFrame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
measure: Changes from baseline in self-reported ankle function
timeFrame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary outcomes:
measure: Changes from baseline in ankle range of motion measured in degrees
timeFrame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
measure: Changes from baseline in ankle maximum voluntary isometric strength
timeFrame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
measure: Changes from baseline in static and dynamic balance
timeFrame: Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: UNC Charlotte
state: North Carolina
Study officials:
References: