NCT00156676

Brief Summary

The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients with gait impairment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable 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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

3 years

First QC Date

September 8, 2005

Last Update Submit

September 18, 2013

Conditions

Multiple Sclerosis

Keywords

DisabilityGaitMultiple SclerosisRehabilitationRobot

Outcome Measures

Primary Outcomes (1)

  • Mean changes and variances in ambulation, motor, fatigue and quality of life

    Timed 25 foot walk

    Baseline, cross-over, study endpoint

Study Arms (2)

Arm 1

EXPERIMENTAL

Cross over from body-weight support treadmill to Lokomat

Device: Body-weight supported treadmillDevice: Lokomat

Arm 2

EXPERIMENTAL

Cross over from Lokomat to body-weight support treadmill

Device: Body-weight supported treadmillDevice: Lokomat

Interventions

Body-weight supported treadmillDEVICE
Arm 1
LokomatDEVICE
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of MS by McDonald criteria. EDSS level between 4-6.5.

You may not qualify if:

  • Cardiovascular: recent MI \< 4 wk, uncontrolled HTN \>190/110 mmHg, Uncontrolled diabetes (blood glucose 2X above the upper limit of normal or non-fasting blood drain).
  • Symptomatic fall in blood pressure (\>30mm Hg), when upright in the body support apparatus, despite medical therapy.
  • Circulatory problems, history of vascular claudication or pitting edema.
  • Cognitive impairment MMSE \< 21.
  • Body weight over 150 kg (structural limits of the Lokomat).
  • Lower extremity injuries that limit range of motion or function.
  • Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
  • Unstable fractures.
  • Pressure sores with any skin breakdown in areas in contact with the body harness or DGO apparatus.
  • Chronic and ongoing alcohol or drug abuse.
  • Pre-morbid, ongoing depression or psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VA Medical Center

Providence, Rhode Island, 02908-4799, United States

Location

Related Publications (2)

  • Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.

    PMID: 18971381RESULT

  • Wier LM, Hatcher MS, Triche EW, Lo AC. Effect of robot-assisted versus conventional body-weight-supported treadmill training on quality of life for people with multiple sclerosis. J Rehabil Res Dev. 2011;48(4):483-92. doi: 10.1682/jrrd.2010.03.0035.

    PMID: 21674396DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Albert Lo, MD PhD

    Providence VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

US(1)