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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: July 1, 2016
Last verified: July 2016
  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:


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 ]
    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:
  • 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. 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.

  • PASAT [ Time Frame: baseline, mid, completion, 3 months post training ] [ Designated as safety issue: No ]
    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


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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)
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)

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
Results First Received: December 30, 2015
Last Updated: July 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 08, 2016