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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00766272 |
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disease can include problems with balance, walking, fatigue, weakness and vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them to fall or have a constant fear of falling. To prevent falling, MS patients rely on equipment, such as walkers and canes. These costs can cause financial difficulties for MS patients and families.
A significant problem that is only recently being studied is the relationship between falling and MS. Recent studies have shown that MS patients fall more often than those without MS, and also fall more than the elderly population. The consequent fear of falling is also an important problem, as those worried about falling will probably change their daily habits to lower their risk. This can mean keeping from certain physical and social activities or even staying indoors. Thus, falls and fear of falling can have negative medical, physical, psychological, and social consequences for the patient.
Improving patients' walking may help reduce falls and the fear of falling. Treadmill training has been shown to improve walking in patients with MS and to lower their risk of falling. One way to train patients on a treadmill is with the use of robots that can help move their limbs in a more normal way. This kind of robot-assisted treadmill training may provide even greater benefits than treadmill training alone.
The study is expected to last 6-7.5 months. One group of participants will receive weekly telephone calls and will be asked questions on other physical activities, falls, and activity limitations the patient had during the week. Participants assigned to robot-assisted treadmill training will receive twice weekly training session for 8 weeks, for a total of 16 sessions. Each session will last about 65 to 90 minutes.
The goal of this study is to see if robot-assisted treadmill training will reduce falls and fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be effective in reducing falls and fear of falling in Parkinson's disease patients. This type of training has not been tested in patients with Multiple Sclerosis. The proposed study will help to address this gap and also provide additional data on other possible improvements due to robot-assisted treadmill training including ambulation, social participation, fatigue, and balance.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Device: Lokomat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Gait Rehabilitation for Multiple Sclerosis Using Robot-Assisted Body-Weight-Supported Treadmill Training (Lokomat) |
Enrollment: | 20 |
Study Start Date: | June 2008 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Body-weight supported treadmill training
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Device: Lokomat
Body-weight will be supported using a harness, which suspends the subject above a motorized treadmill (Lokomat, Hocoma, Zurich, Switzerland). The system also incorporates a robot-driven gait orthotic, called the Lokomat, which will be secured to the subject's lower extremity and pelvis using adjustable cuffs and pads. The Lokomat uses computer-controlled motors to drive the hips and knees toward more normative kinematic patterns for gait.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Rhode Island | |
Providence VA Medical Center | |
Providence, Rhode Island, United States, 02908-4799 |
Principal Investigator: | Albert Lo, MD PhD | Providence VA Medical Center |
Responsible Party: | Department of Veterans Affairs ( Lo, Albert - Principal Investigator ) |
Study ID Numbers: | LO-0003 |
Study First Received: | October 2, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00766272 |
Health Authority: | United States: Federal Government |
Rehabilitation Treadmill MS Gait Robot |
Body Weight Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Congenital Abnormalities Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |