Sensory-Targeted Ankle Rehabilitation Strategies (STARS)
- Conditions
- Chronic Ankle Instability
- Registration Number
- NCT01541657
- Lead Sponsor
- Joel Thompson
- Brief Summary
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. The investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.
- Detailed Description
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. If a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. The participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. After completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. Upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. Upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. Then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Male or female 18-45 years of age
- History of ankle sprain with at least two episodes of "giving way" within the past six months
- Score of ≥ 5 on the Ankle Instability Instrument (AII)
- Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
- Score of ≤ 80% on the FAAM-Sport Subscale.
- Younger than 18 or older than 45 years
- No history of ankle sprain or episodes of "giving way" in the past six months
- Score of ≤ 5 on the Ankle Instability Instrument (AII)
- Score of ≥ 90% on the FAAM-ADL
- Score of ≥ 80% on the FAAM-S.
- An acute ankle sprain within the past 6 weeks.
- Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
- Lower extremity injury within the past 6 months (other than ankle sprains)
- Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Foot and Ankle Ability Measure This will be assessed at 3 time points: Change from Pre-intervention to Post-Intervention, change from Pre-Intervention to 1-month Post-Intervention The Foot and Ankle Ability Measure (FAAM) is a questionnaire used to quantify the amount of self-reported disability a person experiences because of chronic ankle instability. It has two sections which will be used to assess disability associated with activities of daily living and sport activities.
Gait Initiation This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention Gait initiation is a laboratory technique that involves the use of a force plate. Participants are asked to stand on the force plate with feet and step off the force plate with either the right or left foot. The size of the weight shifts a participant makes while taking a step are evaluated using the force plate. Each participant will complete 5 trials stepping with each leg for every time point.
Time to Boundary This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention Time to Boundary is a balance measurement in which a person maintains single leg stance on a force plate for 10 seconds. This measurement technique evaluates the amount of time a person has to make corrections to maintain balance. Each participant will perform 12 trials for each time point. Each leg will be tested 6 times, 3 with eyes open and 3 with eyes closed.
Weight-bearing Lunge Test This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention The Weight-bearing Lunge Test is a measure of ankle dorsiflexion range of motion while the participant stands in front of a wall.
Cutaneous Sensation This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention Each participant will have the sensitivity of the bottom of his/her feet assessed. The investigators will use a set of monofilaments (similar to fishing line) to see how small of a monofilament can be detected when the investigator touches the bottom of his or her foot. Participants will be asked to close their eyes during testing.
Single Limb Balance Error Scoring System Assessment This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention Each participant will be asked to balance on one leg for 20 seconds with eyes closed while standing on the floor. During the test, the investigator will count how many times the participant deviates from the target position (standing on one leg with hands on hips).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Ithaca College
🇺🇸Ithaca, New York, United States
University of North Carolina Charlotte
🇺🇸Charlotte, North Carolina, United States
Ithaca College🇺🇸Ithaca, New York, United States