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Clinical Trials/NCT00607126
NCT00607126
Completed
Phase 1

Robotic Locomotor Training in Persons With Multiple Sclerosis

University of California, Los Angeles1 site in 1 country38 target enrollmentJuly 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of California, Los Angeles
Enrollment
38
Locations
1
Primary Endpoint
Walking Speed as Assessed by 25' Timed Walk
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
August 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Giesser

Clinical Professor of Neurology

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device

Exclusion Criteria

  • Unable to ambulate
  • Within 3 months of exacerbation

Outcomes

Primary Outcomes

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 Outcomes

  • Distance(baseline, mid point, end and 12 weeks after training)
  • Fatigue(baseline, mid, completetion, 3 months post)
  • PASAT(baseline, mid, completion, 3 months post training)

Study Sites (1)

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