External Versus Internal Feedback in Patients With Chronic Ankle Instability

Ankle Injuries Clinical Trial

Official title:

External Versus Internal Feedback on Biomechanics and Self-reported Function in Patients With Chronic Ankle Instability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04131842
• Other study ID #: UNCCharlotte
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: June 17, 2024

Study information

• Verified date: June 2023
• Source: University of North Carolina, Charlotte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 17, 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Inversion Sprain

Intervention

Other:
• External focus of attention visual feedback
Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.
• External focus of attention auditory feedback
Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.
• Internal focus of attention video feedback
Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.
• No feedback
Patients will receive no feedback during the impairment-based rehabilitation program.

Locations

Country	Name	City	State
United States	UNC Charlotte	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Primary	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-month post-intervention, 3-months post-intervention
Secondary	Changes from baseline in ankle range of motion measured in degrees	Four different ankle ranges of motion will be measured	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary	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.	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention
Secondary	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	Immediate post-intervention, 1-month post-intervention, 3-months post-intervention