Clinical trial NCT01541657: Sensory-Targeted Ankle Rehabilitation Strategies (STARS)
Official title: Sensory-Targeted Ankle Rehabilitation Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Ankle Instability
Keywords: Ankle Instability
Sensorimotor Control
Sensory
Postural Control
Balance
Gait
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Ithaca College
name: University of North Carolina, Charlotte
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2012-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female 18-45 years of age
2. History of ankle sprain with at least two episodes of "giving way" within the past six months
3. Score of ≥ 5 on the Ankle Instability Instrument (AII)
4. Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
5. Score of ≤ 80% on the FAAM-Sport Subscale.

Exclusion Criteria:

1. Younger than 18 or older than 45 years
2. No history of ankle sprain or episodes of "giving way" in the past six months
3. Score of ≤ 5 on the Ankle Instability Instrument (AII)
4. Score of ≥ 90% on the FAAM-ADL
5. Score of ≥ 80% on the FAAM-S.
6. An acute ankle sprain within the past 6 weeks.
7. Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
8. Lower extremity injury within the past 6 months (other than ankle sprains)
9. Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.

Primary outcomes:
measure: Foot and Ankle Ability Measure
timeFrame: This will be assessed at 3 time points: Change from Pre-intervention to Post-Intervention, change from Pre-Intervention to 1-month Post-Intervention
measure: Gait Initiation
timeFrame: 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
measure: Time to Boundary
timeFrame: 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
measure: Weight-bearing Lunge Test
timeFrame: 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
measure: Cutaneous Sensation
timeFrame: 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
measure: Single Limb Balance Error Scoring System Assessment
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Ithaca College
state: New York
city: Charlotte
country: United States
facility: University of North Carolina Charlotte
state: North Carolina
Study officials:
affiliation: Ithaca College
name: Patrick O McKeon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Charlotte
name: Erik A Wikstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKeon PO, Wikstrom EA. The effect of sensory-targeted ankle rehabilitation strategies on single-leg center of pressure elements in those with chronic ankle instability: A randomized clinical trial. J Sci Med Sport. 2019 Mar;22(3):288-293. doi: 10.1016/j.jsams.2018.08.017. Epub 2018 Sep 6.