Status:
COMPLETED
The Impact of Real-World Vibration Feedback Gait Retraining on Gait Biomechanics in People With Chronic Ankle Instability
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Academy of Orthopaedic Physical Therapy
Conditions:
Chronic Ankle Instability
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
People with chronic ankle instability (CAI) demonstrate altered gait or walking mechanics which cause people to walk on the outside of their foot and increases the risk of additional ankle sprains, ab...
Detailed Description
Background: There are 3.1 million lateral ankle sprains in the United States per year, of which about 40% will develop persistent limitations leading to chronic ankle instability (CAI). People with CA...
Eligibility Criteria
Inclusion
- CAI group:
- between the ages of 18 - 35 years
- will have a history of at least 1 significant lateral ankle sprain which occurred at least 12 months prior to enrollment defines as a sprain which caused at least 1 day of interrupted physical activity
- have a history of recurrent sprains and/or episodes of "giving way"
- have a sense of ankle instability measured by a score of ≥ 11 on the Identification of Functional Ankle Instability (IdFAI)
- have self-reported functional limitations measured by a score of \< 90% of the Foot and Ankle Ability Measure (FAAM)-Activities of Daily Living subscale and \< 80% on the FAAM-Sport subscale.
Exclusion
- evidence of bilateral CAI using the criteria above
- history of previous surgery in either lower extremity
- history of a fracture requiring realignment in either lower extremity
- an acute (\< 12 weeks from enrollment) injury to either lower extremity
- any condition known to affect gait such as peripheral neuropathy, diabetes, neurological disorders, or neurodegenerative diseases
- knowingly pregnant.
- Criteria for precollected healthy control data Inclusion/ Exclusion Criteria
- between the ages of 18-35 years
- no previous history of lower extremity surgery
- no lower extremity injury history in the past 6 months
- no history of neurological disorders (i.e.: stroke, cerebral palsy, multiple sclerosis, etc.)
- not knowingly pregnant. Patient reported outcomes (ie: FAAM, IdFAI) were not collected as part of the previous study, therefore cannot be used as inclusion or exclusion criteria.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05327244
Start Date
June 9 2022
End Date
April 6 2023
Last Update
June 8 2023
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599