Improving Ambulation Post Stroke With Robotic Training

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Noser, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00975156
First received: September 10, 2009
Last updated: February 20, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Ambulation Post Stroke With Robotic Training

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 10, 2009
Results First Received: August 14, 2012
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014