NCT02025569

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

1.5 years

First QC Date

December 24, 2013

Last Update Submit

December 30, 2013

Conditions

Keywords

chronic ankle instabilitylateral ankle sprainmanual therapystar excursion balance teststrain and counterstrain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Foot and Ankle Ability Measure

    baseline

  • Foot and Ankle Ability Measure

    4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Strain counterstrain intervention

Other: Strain Counterstrain

Control Group

SHAM COMPARATOR

Sham Strain Counterstrain intervention

Other: Sham strain counterstrain

Interventions

Experimental group
Control Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
  • of more episodes of ankle giving way in the last 12 months
  • chronic instability attributed to the original sprain injury
  • age between 18-55

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island University

Brooklyn, New York, 11201, United States

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Cristiana K Collins, PhD

    Long Island University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 24, 2013

First Posted

January 1, 2014

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations