Effects of Proximal and Distal Tibiofibular Joint Manipulation on Lower Extremity Muscle Activation, Ankle Range of Motion, and Functional Outcome Scores in Individuals With Chronic Ankle Instability

June 23, 2010 updated by: University of Virginia

The overall aim of this project is to determine the effect of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles in individuals with chronic ankle instability. Another aim of this study is to determine the long term effects of a tibiofibular joint manipulation on range of motion and self-reported function.

We hypothesize that a manipulation applied at the distal tibiofibular joint will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores compared to a tibiofibular joint manipulation applied at the proximal joint. We further hypothesize that both distal and proximal tibiofibular joint manipulations will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores than no treatment at all.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscle weakness is a common impairment following injury to a joint. Individuals with lateral ankle sprains have been shown to demonstrate weakness and inhibition of the fibularis longus and soleus muscles. Recently, changes in the positional alignment of the talus, tibia, and fibula have been implicated in a subpopulation of individuals with chronic ankle instability (CAI). Clinically this manifests as a decrease in the posterior glide of the talus and decreased dorsiflexion ROM. Another positional fault has been noted to occur between the distal tibiofibular joint. A subpopulation of individuals with a history of CAI have demonstrated a slight anterior displacement of the fibula relative to the tibia. The cause of the malpositioning is unknown, but manual therapeutic interventions may offer the ability to restore normal joint arthrokinematics and muscle function. It is unknown if the correction of this positional fault will have an effect on muscle inhibition about the ankle.

Since muscle inhibition is a neurological reflexive reaction, it is thought that traditional strengthening treatment techniques may not fully address this dysfunction. Manual therapeutic interventions can have dual effects on the neuromuscular system and restore normal joint arthrokinematics. Evidence suggests a joint manipulation is able to disinhibit or even facilitate local and distant muscles. This likely occurs due to the afferent response from the structures in and around the manipulated joint. Comprehensive treatment interventions which restore normal joint function, optimal motoneuron pool excitability, strength, and pain-free previous level of function need to be developed to prevent future dysfunction and osteoarthritis.

Currently no study has examined the effects of tibiofibular joint manipulation on the neuromuscular response of ankle musculature or the effects on range of motion and function. The purpose of this study is to examine the acute effects of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles and to determine the long term effects on range of motion and function in individuals with CAI.

The first research question will address how a tibiofibular joint manipulation immediately affects the activation of the fibularis longus and soleus muscles. The second question will address how this joint manipulation affects range of motion and functional outcomes over a three week period. Changes in ankle dorsiflexion range of motion (ROM), navicular drop, Step Down Test, Balance Error Scoring System, and the Foot and Ankle Ability Measure (FAAM) will be used to determine if clinically significant changes occurred during the intervention period.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of more than one ankle sprain
  • unilateral or bilateral
  • Complaint of chronic ankle instability (CAI) and qualified according to
  • 4 "YES" responses on the Ankle Instability Instrument (AII)
  • Scoring at least an 85 on the Foot and Ankle Ability Measure (FAAM)

Exclusion Criteria:

  • Lower extremity injury in the past 6 months (including lateral ankle sprain)
  • Currently receiving physical therapy for a lower extremity injury
  • Have a previous history of lower extremity surgery
  • Have diagnosed ankle osteoarthritis or rheumatoid arthritis
  • Currently pregnant or breast feeding
  • History of connective tissue disorders (like Marfan's Syndrome or Ehlers Danlos Disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
proximal tibiofibular manipulation
Other: proximal tibiofibular manipulation
proximal tibiofibular manipulation
Experimental: 2
distal tibiofibular manipulation
Other: distal tibiofibular manipulation
distal tibiofibular manipulation
No Intervention: 3
no treatment
Other: no intervention
no intervention / control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in muscle activation
Time Frame: over a three week period
over a three week period

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in functional range of motion
Time Frame: over a 3 week period
over a 3 week period
changes in function
Time Frame: over a three week period
over a three week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

American Physical Therapy Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12966

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Ankle Sprain

Clinical Trials on proximal tibiofibular manipulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe