- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025569
The Effect of Strain-counterstrain on Ankle Instability
December 30, 2013 updated by: Cristiana Kahl Collins, PT, PhD, Long Island University
The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial
This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI).
Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive.
No studies have assessed the effectiveness of SCS on CAI.
Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM).
Participants were randomized into the SCS intervention group or the sham SCS control group.
All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program.
At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form.
The primary aim was examined with a 2-way analysis of variance (ANOVA).
Study Type
Interventional
Enrollment (Actual)
27
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
-
-
New York
-
Brooklyn, New York, United States, 11201
- Long Island University
-
-
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 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
- 3 of more episodes of ankle giving way in the last 12 months
- chronic instability attributed to the original sprain injury
- age between 18-55
Exclusion Criteria:
- history of fracture or surgery in the affected ankle
- any other lower extremity musculoskeletal injury on the side of the involved ankle
- vestibular dysfunction or disorder
- history of balance dysfunction
- history of stroke or any other neurological pathology or disease
- history of ACL injury
- current participation in physical therapy or rehabilitation for the ankle injury
- evidence of CNS dysfunction
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: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
Strain counterstrain intervention
|
|
SHAM_COMPARATOR: Control Group
Sham Strain Counterstrain intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Star Excursion Balance Test
Time Frame: baseline
|
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions.
The distances reached with the non-stance leg are measured.
|
baseline
|
Star Excursion Balance Test
Time Frame: 4 weeks
|
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions.
The distances reached with the non-stance leg are measured.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot and Ankle Ability Measure
Time Frame: baseline
|
This measures assesses ankle function skills subjectively via a questionnaire
|
baseline
|
Foot and Ankle Ability Measure
Time Frame: 4 weeks
|
This measures assesses ankle function skills subjectively via a questionnaire
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cristiana K Collins, PhD, Long Island University
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, 2008
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
December 24, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (ESTIMATE)
January 1, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 30, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CKCollins-SCS
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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