- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607126
Locomotor Training in Persons With Multiple Sclerosis
Robotic Locomotor Training in Persons With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were suspended in a harness while in the Lokomat with full to partial body weight support as needed. After the training in the Lokomat, they practiced overground walking for 10 minutes.
The other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the Lokomat group for intensity, duration and frequency. they did not practice overground walking.
Primary outcome measure was speed to accomplish 25' timed walk.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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California
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Los Angeles, California, United States, 90095
- UCLA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device
Exclusion Criteria:
- Ataxia
- Unable to ambulate
- Within 3 months of exacerbation
Study Plan
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: 1
locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training.
Locomotor training will be done using the Lokomat device.
the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill.
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locomotor training using body weight support on a treadmill
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Active Comparator: 2
resistive training using weights and therabands
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resistive training using theraband and/or weights
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking Speed as Assessed by 25' Timed Walk
Time Frame: at beginning,mid point, end and 12 weeks after intervention
|
This is the time needed for participant to walk 25 feet.
Participant walks on a level surface.
the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.
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at beginning,mid point, end and 12 weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance
Time Frame: baseline, mid point, end and 12 weeks after training
|
distance assessed by 6 minute walk test
|
baseline, mid point, end and 12 weeks after training
|
Fatigue
Time Frame: baseline, mid, completetion, 3 months post
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fatigue assessed by modified fatigue impact scale.
This is a 21 item questionnaire which has a range from 0-84.
Higher scores indicate more impact of fatigue on physical and cognitive functioning.
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baseline, mid, completetion, 3 months post
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PASAT
Time Frame: baseline, mid, completion, 3 months post training
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Cognitive measure of attention and information processing speed.
Score goes from 0-60 with higher number indicating better performance.
Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance
|
baseline, mid, completion, 3 months post training
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara S Giesser, MD, University of California, Los Angeles
Publications and helpful links
General Publications
- Giesser B, Beres-Jones J, Budovitch A, Herlihy E, Harkema S. Locomotor training using body weight support on a treadmill improves mobility in persons with multiple sclerosis: a pilot study. Mult Scler. 2007 Mar;13(2):224-31. doi: 10.1177/1352458506070663.
- Giesser B, Herlihy E, Plummer D'Amato P et al. Randomized controlled trial of robotic locomotor training in persons with MS. Multiple Sclerosis Journal 17S481 ( 2011)
- Giesser B, Herlihy, E, PlummerD'Amato P, et al. Locomotor training may improve cognitive performance in persons with MS. Neurology 72 ( Suppl.3) A 405 (2009)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-04-064-02
- RG3724-A-4 (Other Identifier: National MS Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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