Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities
April 7, 2014 updated by: Jennifer Fawcett, Mount Sinai Rehabilitation Hospital
Targeted Lower Extremity Joint Training Effects on MS Gait Abnormalities
This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop."
The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
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
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Connecticut
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Hartford, Connecticut, United States, 06112
- Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
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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
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical Diagnosis of MS
- EDSS level between 3.5 - 6.0
- Unilateral foot-drop
- Able to ambulate 25 ft. with no more than a unilateral assistive device
Exclusion Criteria:
- Lower extremity injuries that limit range of motion or function
- Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment
- Unable to fit safely and properly into the Ankle-Bot device
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ankle-Bot Training
Subjects in this group receive focused ankle training using the ankle-bot device.
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The Ankle-bot is a piece of robotic therapy equipment for the ankle.
In this study, it will be used to guide and assist the subject into ankle flexion, extension, inversion and eversion.
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Active Comparator: Conventional Therapy
Subjects in this group will receive conventional focused ankle physical therapy.
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Conventional focused ankle therapy will be performed by a physical therapist.
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No Intervention: Control
Subjects in this group will not receive treatment; they will continue their usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gait Parameters
Time Frame: Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
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Baseline, throughout study enrollment, and at 1 month and 3 month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Albert Lo, M.D., Ph. D., Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 20, 2009
First Submitted That Met QC Criteria
May 20, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Estimate)
April 9, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL0002
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.