Locomotor Training in Persons With Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by University of California, Los Angeles. Recruitment status was Active, not recruiting

First Received on January 22, 2008. Last Updated on February 13, 2009 History of Changes

Sponsor:	University of California, Los Angeles
Collaborator:	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 while they are suspended in a harness.

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

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:

MedlinePlus related topics: Multiple Sclerosis

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:

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:	August 2009
Estimated 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	Device: Lokomat locomotor training using body weight support on a treadmill
Active Comparator: 2 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

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, 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.

Responsible Party:	Barbara Giesser, MD, UCLA School of Medicine
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:	February 13, 2009
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 February 09, 2012