The Effect of Strain-counterstrain on Ankle Instability

Other Instability, Ankle and Foot Clinical Trial

Official title:

The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02025569
• Other study ID #: CKCollins-SCS
• Status: Terminated
• Phase: N/A
• First received: December 24, 2013
• Last updated: December 30, 2013
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2013
• Source: Long Island University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Instability, Ankle and Foot

Intervention

Other:
• Strain Counterstrain

• Sham strain counterstrain

Locations

Country	Name	City	State
United States	Long Island University	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Long Island University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline	No
Primary	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.	4 weeks	No
Secondary	Foot and Ankle Ability Measure	This measures assesses ankle function skills subjectively via a questionnaire	baseline	No
Secondary	Foot and Ankle Ability Measure	This measures assesses ankle function skills subjectively via a questionnaire	4 weeks	No