The Effects of Gentle Movements at the Ankle in Individuals With Diminished Range of Motion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Athletic Training Association Research & Education Foundation
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01119092
First received: May 5, 2010
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

The purpose of this study is the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion.


Condition Intervention
Lateral Ankle Sprain
Other: Sham ("laying of hands") intervention
Other: Grade IV AP joint mobilizations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Change in dorsiflexion range of motion [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in posterior talar glide [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in posterior talar translation [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in self reported function [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change in ankle stiffness [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham intervention plus standard treatment
This group will receive a "laying of hands" treatment in addition to standard treatment. The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.
Other: Sham ("laying of hands") intervention
The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.
No Intervention: Control Group
This group will be individuals who suffer from the same injury but will be instructed to stretch at home 5 days a week for 2 weeks.
Experimental: Grade IV AP joint mobilization plus standard treatment
This group will receive 3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.
Other: Grade IV AP joint mobilizations
3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.

Detailed Description:

The purpose of this study is the examine the effects of a grade IV anterior to posterior joint mobilization and stretching on self-reported function, dorsiflexion range of motion, talar glide and stiffness in individuals who have suffered from an ankle sprain within the last year and have a 5° dorsiflexion range of motion deficit.

We will quantify range of motion with standard goniometric measures, stiffness with the use of an instrumented ankle arthrometer, talar glide with the use of the posterior talar glide test and self-reported function using the foot and ankle ability measure (FAAM) and FAAM-sport.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of a lateral ankle sprain within the last year
  • Dorsiflexion range of motion deficit of 5°
  • Return to full activity prior to participation in this study
  • Individuals with dorsiflexion range of motion that is less than degrees of dorsiflexion.

Exclusion Criteria:

  • A history of ankle surgery that involves intra-articular fixation
  • Syndesmotic ankle sprain (to be ruled out based on the attending certified athletic trainers diagnosis)
  • A history or signs of reflex sympathetic dystrophy
  • Suffer from an acute injury in the lower extremity within the last 6 weeks
  • Have received manual therapy for the ankle sprain prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119092

Contacts
Contact: Nicole Cosby 951-515-3054 nlb4v@virginia.edu
Contact: Jay Hertel, PhD 434-243-8673 jayhertel@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jay Hertel, PhD    434-243-8673    jayhertel@aol.com   
Contact: Nicole Cosby    951-515-3054    nlb4v@virginia.edu   
Principal Investigator: Jay Hertel, MD         
Sponsors and Collaborators
University of Virginia
National Athletic Training Association Research & Education Foundation
Investigators
Principal Investigator: Jay Hertel, PhD University to Virginia
  More Information

No publications provided

Responsible Party: Jay Hertel, University of Virginia
ClinicalTrials.gov Identifier: NCT01119092     History of Changes
Other Study ID Numbers: 14787, 14794
Study First Received: May 5, 2010
Last Updated: May 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Ankle Sprain
Joint Mobilization
Manual Therapy
Range of Motion

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 28, 2014