The Effect of Strain-counterstrain on Ankle Instability
Primary Purpose
Other Instability, Ankle and Foot
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strain Counterstrain
Sham strain counterstrain
Sponsored by
About this trial
This is an interventional treatment trial for Other Instability, Ankle and Foot focused on measuring chronic ankle instability, lateral ankle sprain, manual therapy, star excursion balance test, strain and counterstrain
Eligibility Criteria
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
Sites / Locations
- Long Island University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control Group
Arm Description
Strain counterstrain intervention
Sham Strain Counterstrain intervention
Outcomes
Primary Outcome Measures
Star Excursion Balance Test
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.
Star Excursion Balance Test
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.
Secondary Outcome Measures
Foot and Ankle Ability Measure
This measures assesses ankle function skills subjectively via a questionnaire
Foot and Ankle Ability Measure
This measures assesses ankle function skills subjectively via a questionnaire
Full Information
NCT ID
NCT02025569
First Posted
December 24, 2013
Last Updated
December 30, 2013
Sponsor
Long Island University
1. Study Identification
Unique Protocol Identification Number
NCT02025569
Brief Title
The Effect of Strain-counterstrain on Ankle Instability
Official Title
The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Data collection was terminated due to unavailability of additional participants.
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Long Island University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Instability, Ankle and Foot
Keywords
chronic ankle instability, lateral ankle sprain, manual therapy, star excursion balance test, strain and counterstrain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Strain counterstrain intervention
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham Strain Counterstrain intervention
Intervention Type
Other
Intervention Name(s)
Strain Counterstrain
Intervention Type
Other
Intervention Name(s)
Sham strain counterstrain
Primary Outcome Measure Information:
Title
Star Excursion Balance Test
Description
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.
Time Frame
baseline
Title
Star Excursion Balance Test
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Foot and Ankle Ability Measure
Description
This measures assesses ankle function skills subjectively via a questionnaire
Time Frame
baseline
Title
Foot and Ankle Ability Measure
Description
This measures assesses ankle function skills subjectively via a questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiana K Collins, PhD
Organizational Affiliation
Long Island University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Strain-counterstrain on Ankle Instability
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