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Locomotor Training in Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00607126
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Barbara Giesser, University of California, Los Angeles

Study Description
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Brief Summary:
Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Lokomat Procedure: resistive training Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Locomotor Training in Persons With Multiple Sclerosis
Study Start Date : July 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Device: Lokomat
locomotor training using body weight support on a treadmill
Active Comparator: 2
resistive training using weights and therabands
 Procedure: resistive training
resistive training using theraband and/or weights


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Distance [ Time Frame: baseline, mid point, end and 12 weeks after training ]
    distance assessed by 6 minute walk test

  2. Fatigue [ Time Frame: baseline, mid, completetion, 3 months post ]
    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.

  3. PASAT [ Time Frame: baseline, mid, completion, 3 months post training ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607126


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Barbara S Giesser, MD University of California, Los Angeles
More Information
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Publications of Results:
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)

Other Publications:
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)

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Responsible Party: Barbara Giesser, Clinical Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00607126    
Other Study ID Numbers: 06-04-064-02
RG3724-A-4 ( Other Identifier: National MS Society )
First Posted: February 5, 2008    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Barbara Giesser, University of California, Los Angeles:
impaired ambulation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases