- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01790581
Balance Training vs. Balance Training w/ STARS
July 6, 2017 updated by: University of North Carolina, Charlotte
Chronic Ankle Instability (CAI) is a health condition that results in repeated ankle sprains and other residual impairments.
CAI has been linked to many different causative factors including sensory and motor deficits that affect the global function of the sensorimotor system as well as the patient.
Over the past 20 years, strong evidence has been generated to support balance training as an effective intervention strategy in the CAI population.
Unfortunately, most investigations have focused solely on maximizing motor output through balance training, while ignoring the full spectrum of sensorimotor dysfunction associated with CAI.
There may be advantageous sensory-targeted interventions that augment the effects of balance training and lead to greater enhancements of functional outcomes for CAI.
However, this possibility has not been systematically explored.
Sensory-targeted ankle rehabilitation strategies (STARS), such as joint mobilization and plantar massage have resulted in improved sensorimotor function in those with CAI.
However, only a single STARS (i.e.
stochastic resonance) has been investigated in combination with balance training.
While the combined effects were greater than those of balance training alone, stochastic resonance requires relatively expensive equipment that is not commercially available.
Thus, the purpose of this investigation is to test the hypothesis that combining low cost STARS (e.g.
plantar massage and joint mobilizations) with balance training will result in greater sensorimotor and functional improvements in those with CAI than balance training alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28223
- University of North Carolina at Charlotte
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females between the ages of 18 and 35.
- A history of at least one episode of "giving way" within the past 3 months.
- Answering 4 or more questions of "Yes" on the Ankle Instability Instrument (AII).
- Score of <90% on the self-reported Foot and Ankle Ability Measure (FAAM).
- Score of <80% on the FAAM Sport.
Exclusion Criteria:
- Failing to meet the inclusion criteria.
- Known balance and vision problems.
- Acute lower extremities and head injuries that occurred <6 weeks ago.
- Chronic musculoskeletal conditions known to affect balance.
- A history of ankle surgeries to fix internal derangements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Balance Training
|
This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function.
During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions.
The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
|
Experimental: Balance Training w/ STARS
|
This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function.
During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions.
The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage.
These four techniques target 3 types of sensory pathways (musculotendinous, articular, and plantar cutaneous, respectively) and will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Balance at 1-day post intervention
|
Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT).
This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
|
Balance at 1-day post intervention
|
Self-assessed Disability
Time Frame: Disability to 1-day post intervention
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2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed.
The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32).
Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89,
SEM= 2.1 and r=0.87,
SEM= 4.5, respectively) in people with CAI.
|
Disability to 1-day post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Change from baseline balance at 1-week post intervention
|
Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT).
This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).
|
Change from baseline balance at 1-week post intervention
|
Self-assessed Disability
Time Frame: Change from baseline disability at 1-week post intervention
|
2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed.
The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
|
Change from baseline disability at 1-week post intervention
|
Self-assessed Disability
Time Frame: Change from baseline disability at 1-month post intervention
|
3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed.
The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.
|
Change from baseline disability at 1-month post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Erik A Wikstrom, PhD, University of North Carolina at Charlotte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 8, 2013
First Submitted That Met QC Criteria
February 11, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Actual)
July 11, 2017
Last Update Submitted That Met QC Criteria
July 6, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UNCC12-09-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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