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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01119092
Other study ID # 14787
Secondary ID 14794
Status Recruiting
Phase N/A
First received May 5, 2010
Last updated May 26, 2011
Start date January 2010
Est. completion date May 2011

Study information

Verified date May 2011
Source University of Virginia
Contact Nicole Cosby
Phone 951-515-3054
Email nlb4v@virginia.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia National Athletic Training Association Research & Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in dorsiflexion range of motion Baseline and 4 weeks No
Primary Change in posterior talar glide Baseline and 4 weeks No
Primary Change in posterior talar translation Baseline and 4 weeks No
Secondary Change in self reported function Baseline and 4 weeks No
Secondary Change in ankle stiffness Baseline and 4 weeks No
See also
  Status Clinical Trial Phase
Unknown status NCT01210612 - The Effect of Five-Toed Socks on Postural Control Among Active Individuals Who Have Chronic Ankle Instabilities N/A
Terminated NCT00761865 - Lateral Ankle Sprain Study N/A
Completed NCT00639028 - Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS) N/A
Recruiting NCT05815576 - Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability N/A