NCT00075283

Brief Summary

The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2004

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2004

First QC Date

January 8, 2004

Last Update Submit

June 23, 2005

Conditions

HemiparesisStroke

Keywords

Physical TherapyLocomotion therapyGait trainingStrokeRoboticsRehabilitationTreadmillHemiparetic strokeUnilateral brain lesion

Interventions

Lokomat (Robotic Orthosis) combined with slat belt treadmillDEVICE

Eligibility Criteria

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

You may qualify if:

  • Unilateral brain lesion.
  • Within 6 months post-stroke.
  • Receiving no other therapy targeting function of lower limb.
  • Demonstration of hemiparesis (motor dysfunction in lower limb).
  • Able to walk 5 meters without therapist assistance (walking device only).
  • Able to follow commands and protocol.

You may not qualify if:

  • Significant cognitive or communication impairments.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes.
  • Clinical depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

ParesisStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dr. Joseph M Hidler, Ph.D.

    The Catholic University of America

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl M Lacsamana, BBE

CONTACT

(202)877-1889cheryl.lacsamana@medstar.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 8, 2004

First Posted

January 9, 2004

Study Start

November 1, 2002

Last Updated

June 24, 2005

Record last verified: 2004-01

Locations

US(1)