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

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.

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

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.

Clinical Trials on Other Instability, Ankle and Foot

Clinical Trials on Strain Counterstrain

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