Locomotor Training in Persons With Multiple Sclerosis
Procedure: resistive training
|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|
- 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 ]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.
- Distance [ Time Frame: baseline, mid point, end and 12 weeks after training ] [ Designated as safety issue: No ]distance assessed by 6 minute walk test
- Fatigue [ Time Frame: baseline, mid, completetion, 3 months post ] [ Designated as safety issue: No ]fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.
- PASAT [ Time Frame: baseline, mid, completion, 3 months post training ] [ Designated as safety issue: No ]Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance
|Study Start Date:||July 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.
locomotor training using body weight support on a treadmill
Active Comparator: 2
resistive training using weights and therabands
Procedure: resistive training
resistive training using theraband and/or weights
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607126
|United States, California|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Barbara S Giesser, MD||University of California, Los Angeles|