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
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 24, 2010
June 1, 2010
2.8 years
January 14, 2008
June 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in muscle activation
over a three week period
Secondary Outcomes (2)
changes in functional range of motion
over a 3 week period
changes in function
over a three week period
Study Arms (3)
1
EXPERIMENTALproximal tibiofibular manipulation
2
EXPERIMENTALdistal tibiofibular manipulation
3
NO INTERVENTIONno treatment
Interventions
Eligibility Criteria
You may qualify if:
- History of more than one ankle sprain
- unilateral or bilateral
- Complaint of chronic ankle instability (CAI) and qualified according to
- "YES" responses on the Ankle Instability Instrument (AII)
- Scoring at least an 85 on the Foot and Ankle Ability Measure (FAAM)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- American Physical Therapy Associationcollaborator
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Hertel, PhD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 14, 2008
First Posted
January 28, 2008
Study Start
April 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 24, 2010
Record last verified: 2010-06