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Improving Ambulation Post Stroke With Robotic Training

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975156
First Posted: September 11, 2009
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Noser, The University of Texas Health Science Center, Houston
  Purpose
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.

Condition Intervention
Stroke Other: Physical Therapy Device: Lokomat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Ambulation Post Stroke With Robotic Training

Further study details as provided by Elizabeth Noser, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 6 Minute Walking Distance (6MWD) [ Time Frame: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention ]

Enrollment: 21
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat Intervention
Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).
Device: Lokomat
Robotic-assisted walking device
Active Comparator: Standard of Care
Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.
Other: Physical Therapy
Conventional physical therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • Age>18
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975156


Locations
United States, Texas
Memorial Hermann
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Elizabeth Noser, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Elizabeth Noser, Clinical Assistant Professor - Neurology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00975156     History of Changes
Other Study ID Numbers: HSC-MH-08-0206
Medallion Grant
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: August 14, 2012
Results First Posted: September 13, 2012
Last Update Posted: February 25, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases