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Clinical Trials/NCT00975156
NCT00975156
Completed
N/A

Improving Ambulation Post Stroke With Robotic Training

The University of Texas Health Science Center, Houston1 site in 1 country21 target enrollmentMay 2008
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
21
Locations
1
Primary Endpoint
10-meter Walking Test (10mWT)
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Noser

Clinical Assistant Professor - Neurology

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • At least 3 months post stroke at time of enrollment into study
  • Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
  • Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4
  • Ability to perform Lokomat ambulation training with assistance of 1 therapist
  • Ability to follow a three-step command
  • Physician approval for patient participation
  • Ability to give informed consent
  • Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies

Exclusion Criteria

  • Serious cardiac condition
  • Uncontrolled blood pressure, defined as \> 200 or diastolic \> 100 at rest
  • Hx of serious chronic obstructive pulmonary disease or oxygen dependence
  • Sever weight bearing pain
  • Lower extremity amputation
  • Claudication while walking
  • Life expectancy \< 1 year
  • History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months
  • Severe orthopedic problem
  • Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study

Outcomes

Primary Outcomes

10-meter Walking Test (10mWT)

Time Frame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Secondary Outcomes

  • 6 Minute Walking Distance (6MWD)(Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention)

Study Sites (1)

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