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

Primary Purpose

Lateral Ankle Sprain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham ("laying of hands") intervention
Grade IV AP joint mobilizations
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Ankle Sprain focused on measuring Ankle Sprain, Joint Mobilization, Manual Therapy, Range of Motion

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

No Intervention

Experimental

Arm Label

Sham intervention plus standard treatment

Control Group

Grade IV AP joint mobilization plus standard treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in dorsiflexion range of motion
Change in posterior talar glide
Change in posterior talar translation

Secondary Outcome Measures

Change in self reported function
Change in ankle stiffness

Full Information

First Posted
May 5, 2010
Last Updated
May 26, 2011
Sponsor
University of Virginia
Collaborators
National Athletic Training Association Research & Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01119092
Brief Title
The Effects of Gentle Movements at the Ankle in Individuals With Diminished Range of Motion
Official Title
The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Athletic Training Association Research & Education Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Ankle Sprain
Keywords
Ankle Sprain, Joint Mobilization, Manual Therapy, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham intervention plus standard treatment
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Grade IV AP joint mobilization plus standard treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sham ("laying of hands") intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Grade IV AP joint mobilizations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in dorsiflexion range of motion
Time Frame
Baseline and 4 weeks
Title
Change in posterior talar glide
Time Frame
Baseline and 4 weeks
Title
Change in posterior talar translation
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in self reported function
Time Frame
Baseline and 4 weeks
Title
Change in ankle stiffness
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Cosby
Phone
951-515-3054
Email
nlb4v@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Hertel, PhD
Phone
434-243-8673
Email
jayhertel@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Hertel, PhD
Organizational Affiliation
University to Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Hertel, PhD
Phone
434-243-8673
Email
jayhertel@aol.com
First Name & Middle Initial & Last Name & Degree
Nicole Cosby
Phone
951-515-3054
Email
nlb4v@virginia.edu
First Name & Middle Initial & Last Name & Degree
Jay Hertel, MD

12. IPD Sharing Statement

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

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