- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432705
Changes in Unstable Ankles After Balance Training
July 21, 2009 updated by: University of North Carolina, Charlotte
Modulation of Sensorimotor Measures in Chronically Unstable Ankles
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles.
We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement.
This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training.
It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI).
Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI.
These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity.
This study seeks to modulate sensorimotor measures through both short- and long-term reflex training.
This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
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 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy
Exclusion Criteria:
- ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing
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: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postural control
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: JoEllen M. Sefton, MS, ATC, CMT, UNC Charlotte
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
September 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
February 6, 2007
First Submitted That Met QC Criteria
February 6, 2007
First Posted (Estimate)
February 8, 2007
Study Record Updates
Last Update Posted (Estimate)
July 22, 2009
Last Update Submitted That Met QC Criteria
July 21, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-11-34-CAI-B
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.
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