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Locomotor Training in Persons With Multiple Sclerosis

This study is currently recruiting participants.
Verified by University of California, Los Angeles, January 2008

Sponsors and Collaborators: University of California, Los Angeles
National Multiple Sclerosis Society
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00607126
  Purpose

Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It ihas 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 whle they are suspended in a harness.


Condition Intervention Phase
Multiple Sclerosis
Device: Lokomat
Procedure: resistive training
Phase I
Phase II

MedlinePlus related topics:   Multiple Sclerosis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Robotic Locomotor Training in Persons With Multiple Sclerosis

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:
  • accelerometry data [ Time Frame: baseline, mid point, end and 12 weeks after training ] [ Designated as safety issue: No ]

Estimated Enrollment:   40
Study Start Date:   July 2006
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training
Device: Lokomat
locomotor training using body weight support on a treadmill
2: Active Comparator
resistive training
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

Contacts
Contact: Elise Herlihy, RN, MSN     310 267-4071     eherlihy@mednet.ucla.edu    

Locations
United States, California
UCLA     Recruiting
      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:

Responsible Party:   UCLA School of Medicine ( Barbara Giesser, MD )
Study ID Numbers:   06-04-064-02, RG3724-A-4
First Received:   January 22, 2008
Last Updated:   February 4, 2008
ClinicalTrials.gov Identifier:   NCT00607126
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 06, 2008




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