- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01119092
The Effects of Gentle Movements at the Ankle in Individuals With Diminished Range of Motion
The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Cosby
- Phone Number: 951-515-3054
- Email: nlb4v@virginia.edu
Study Contact Backup
- Name: Jay Hertel, PhD
- Phone Number: 434-243-8673
- Email: jayhertel@virginia.edu
Study Locations
-
-
Virginia
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Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
-
Contact:
- Nicole Cosby
- Phone Number: 951-515-3054
- Email: nlb4v@virginia.edu
-
Contact:
- Jay Hertel, PhD
- Phone Number: 434-243-8673
- Email: jayhertel@aol.com
-
Principal Investigator:
- Jay Hertel, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in dorsiflexion range of motion
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Change in posterior talar glide
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Change in posterior talar translation
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in self reported function
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Change in ankle stiffness
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jay Hertel, PhD, University to Virginia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14787
- 14794 (Other Grant/Funding Number: National Athletic Trainers' Association Research & Education Foundation)
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.
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