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Locomotor Training in Persons With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Barbara Giesser, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00607126
First received: January 22, 2008
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis
 Device: Lokomat
Procedure: resistive training
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Locomotor Training in Persons With Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • walking speed as assessed by 25' timed walk [ Time Frame: at beginning,mid point, end and 12 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • distance [ Time Frame: baseline, mid point, end and 12 weeks after training ] [ Designated as safety issue: No ]
    distance assessed by 6 minute walk test

  • fatigue [ Time Frame: baseline, mid, completetion, 3 months post ] [ Designated as safety issue: No ]
    fatigue assessed by modified fatigue impact scale

  • PASAT [ Time Frame: baseline, mid, completion, 3 months post training ] [ Designated as safety issue: No ]
    Cognitive measure of attention and information processing speed


Enrollment: 38
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons with SP or PP MS who are ambulatory with difficulty and /or assistive device

Exclusion Criteria:

  • Ataxia
  • Unable to ambulate
  • Within 3 months of exacerbation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607126

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

Publications:
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)

Responsible Party: Barbara Giesser, Clinical Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00607126     History of Changes
Other Study ID Numbers: 06-04-064-02, RG3724-A-4
Study First Received: January 22, 2008
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
impaired ambulation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013