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Completed

NCT Number: NCT00607126

Locomotor Training in Persons With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lokomat

Device

locomotor training using body weight support on a treadmill

resistive training

Procedure

resistive training using theraband and/or weights

Primary outcomes

  1. 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

  1. Distance

    Time frame: baseline, mid point, end and 12 weeks after training

    distance assessed by 6 minute walk test

  2. Fatigue

    Time frame: baseline, mid, completetion, 3 months post

    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.

  3. PASAT

    Time frame: baseline, mid, completion, 3 months post training

    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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

Robotic Locomotor Training in Persons With Multiple Sclerosis

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2008
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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