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
Primary Purpose
Ankle Sprain, Ankle Injuries, Sprain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
proximal tibiofibular manipulation
distal tibiofibular manipulation
no intervention
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain focused on measuring ankle sprain, ankle injuries, sprains and strains
Eligibility Criteria
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)
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
proximal tibiofibular manipulation
distal tibiofibular manipulation
no treatment
Outcomes
Primary Outcome Measures
Changes in muscle activation
Secondary Outcome Measures
changes in functional range of motion
changes in function
Full Information
NCT ID
NCT00601471
First Posted
January 14, 2008
Last Updated
June 23, 2010
Sponsor
University of Virginia
Collaborators
American Physical Therapy Association
1. Study Identification
Unique Protocol Identification Number
NCT00601471
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
Collaborators
American Physical Therapy Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain, Ankle Injuries, Sprain
Keywords
ankle sprain, ankle injuries, sprains and strains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
proximal tibiofibular manipulation
Arm Title
2
Arm Type
Experimental
Arm Description
distal tibiofibular manipulation
Arm Title
3
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Other
Intervention Name(s)
proximal tibiofibular manipulation
Intervention Description
proximal tibiofibular manipulation
Intervention Type
Other
Intervention Name(s)
distal tibiofibular manipulation
Intervention Description
distal tibiofibular manipulation
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
no intervention / control
Primary Outcome Measure Information:
Title
Changes in muscle activation
Time Frame
over a three week period
Secondary Outcome Measure Information:
Title
changes in functional range of motion
Time Frame
over a 3 week period
Title
changes in function
Time Frame
over a three week period
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Hertel, PhD
Organizational Affiliation
University of 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
12. IPD Sharing Statement
Learn more about this trial
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
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