NCT00607126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2006

Typical duration for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
7 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

July 1, 2016

Enrollment Period

3.1 years

First QC Date

January 22, 2008

Results QC Date

December 30, 2015

Last Update Submit

July 1, 2016

Conditions

Multiple Sclerosis

Keywords

impaired ambulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    at beginning,mid point, end and 12 weeks after intervention

Secondary Outcomes (3)

  • Distance

    baseline, mid point, end and 12 weeks after training

  • Fatigue

    baseline, mid, completetion, 3 months post

  • PASAT

    baseline, mid, completion, 3 months post training

Study Arms (2)

1

EXPERIMENTAL

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.

Device: Lokomat

2

ACTIVE COMPARATOR

resistive training using weights and therabands

Procedure: resistive training

Interventions

LokomatDEVICE

locomotor training using body weight support on a treadmill

1
resistive trainingPROCEDURE

resistive training using theraband and/or weights

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device

You may not qualify if:

  • Ataxia
  • Unable to ambulate
  • Within 3 months of exacerbation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • 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.

    PMID: 17450642BACKGROUND

  • 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)

    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)

    RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

This was a small study and the number of subjects enrolled may not have been sufficient to show an effect.

Results Point of Contact

Title
Barbara Giesser,MD
Organization
DAvdi Geffen School of Medicine at UCLA
bgiesser@mednet.ucla.edu
310-825-7313

Study Officials

  • Barbara S Giesser, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Neurology

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

July 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 15, 2016

Results First Posted

August 15, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)