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Locomotor Training in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lokomat
resistive training
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring impaired ambulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

resistive training using weights and therabands

Outcomes

Primary Outcome Measures

Walking Speed as Assessed by 25' Timed Walk
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 Outcome Measures

Distance
distance assessed by 6 minute walk test
Fatigue
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
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

Full Information

First Posted
January 22, 2008
Last Updated
July 1, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT00607126
Brief Title
Locomotor Training in Persons With Multiple Sclerosis
Official Title
Robotic Locomotor Training in Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
impaired ambulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
resistive training using weights and therabands
Intervention Type
Device
Intervention Name(s)
Lokomat
Intervention Description
locomotor training using body weight support on a treadmill
Intervention Type
Procedure
Intervention Name(s)
resistive training
Intervention Description
resistive training using theraband and/or weights
Primary Outcome Measure Information:
Title
Walking Speed as Assessed by 25' Timed Walk
Description
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.
Time Frame
at beginning,mid point, end and 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Distance
Description
distance assessed by 6 minute walk test
Time Frame
baseline, mid point, end and 12 weeks after training
Title
Fatigue
Description
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.
Time Frame
baseline, mid, completetion, 3 months post
Title
PASAT
Description
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
Time Frame
baseline, mid, completion, 3 months post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara S Giesser, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17450642
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.
Results Reference
background
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)
Results Reference
background
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)
Results Reference
result

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Locomotor Training in Persons With Multiple Sclerosis

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