Locomotor Training in Persons With Multiple Sclerosis

NCT ID: NCT00607126

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-08-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lokomat

Intervention Type: DEVICE

locomotor training using body weight support on a treadmill

2

resistive training using weights and therabands

Group Type: ACTIVE_COMPARATOR

resistive training

Intervention Type: PROCEDURE

resistive training using theraband and/or weights

Interventions

Lokomat

locomotor training using body weight support on a treadmill

Intervention Type: DEVICE

resistive training

resistive training using theraband and/or weights

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Barbara Giesser

Clinical Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara S Giesser, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Countries

United States

References

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. doi: 10.1177/1352458506070663.

Reference Type: BACKGROUND

PMID: 17450642 (View on PubMed)

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)

Reference Type: BACKGROUND

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)

Reference Type: RESULT

Other Identifiers

RG3724-A-4

Identifier Type: OTHER

Identifier Source: secondary_id

06-04-064-02

Identifier Type: -

Identifier Source: org_study_id