Clinical trial NCT00607126: Locomotor Training in Persons With Multiple Sclerosis
Official title: Robotic Locomotor Training in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: impaired ambulation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2008-02-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Walking Speed as Assessed by 25' Timed Walk
timeFrame: at beginning,mid point, end and 12 weeks after intervention
Secondary outcomes:
measure: Distance
timeFrame: baseline, mid point, end and 12 weeks after training
measure: Fatigue
timeFrame: baseline, mid, completetion, 3 months post
measure: PASAT
timeFrame: baseline, mid, completion, 3 months post training
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Barbara S Giesser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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)
citation: 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)