Trial record 9 of 9 for:    Open Studies | "Athletic Injuries"

Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains

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:
American Physical Therapy Association
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01117909
First received: May 4, 2010
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.


Condition Intervention
Ankle Sprain
Other: Mobilization therapy in addition to standard therapy
Other: Sham intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Change in self-reported function [ Time Frame: Baseline and four weeks ] [ Designated as safety issue: No ]
    We hypothesize that the group that receives joint mobilization in addition to standard therapy will show greater improvements in Functional Ankle and Ability Measure (FAAM) and FAAM-Sport (FAAM-S) scores than those who receive standard therapy alone.

  • Change in self-reported pain [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    We hypothesize visual analog scale (VAS) scores for pain will have a greater improvement in those who received joint mobilization in addition to standard therapy when compared to standard therapy alone.


Secondary Outcome Measures:
  • Change in ankle dorsiflexion range of motion [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    We hypothesize that mobilization when applied to the talocrural joint in addition to standard therapy will result in a greater increase of ankle dorsiflexion ROM than just standard therapy alone.

  • Change in ligamentous laxity [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    We hypothesize that ligamentous laxity in both groups will be reduced.


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: "Laying of hands" plus standard therapy
Subjects will lie on their back as if they were receiving the joint mobilization treatment and the therapist will place their hands in a position as if to perform the mobilization but no movement will occur. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression
Other: Sham intervention
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
Experimental: Standard therapy with joint mobilization
This group will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session, in addition to standard therapy. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression
Other: Mobilization therapy in addition to standard therapy
Subject will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression.

Detailed Description:

The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.

  Eligibility

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

Inclusion Criteria:

  • Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
  • Slight reduction in function
  • Anterolateral ankle tenderness
  • Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
  • Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
  • Posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10
  • Suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days

Exclusion Criteria:

  • A history of ankle surgery that involves intra-articular fixation,
  • Syndesmotic ankle sprain (to be ruled out based on clinical examination),
  • History or signs of reflex sympathetic dystrophy,
  • Have received manual therapy for the ankle sprain prior to enrollment
  • Grade III ankle sprain.
  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: NCT01117909

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Terry Grindstaff, PhD, DPT    434-243-2430    tlg6q@virginia.edu   
Contact: Nicole Cosby, MS, ATC    434-924-6184    nlb4v@virginia.edu   
Sponsors and Collaborators
University of Virginia
American Physical Therapy Association
Investigators
Principal Investigator: Terry Grindstaff, PhD, DPT University of Virginia
  More Information

No publications provided

Responsible Party: Dr. Terry Grindstaff, University of Virginia
ClinicalTrials.gov Identifier: NCT01117909     History of Changes
Other Study ID Numbers: 14919
Study First Received: May 4, 2010
Last Updated: May 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
ankle sprain
athletic injury
arthritis

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

ClinicalTrials.gov processed this record on September 14, 2014