Improving Ambulation Post Stroke With Robotic Training

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

Conventional physical therapy

Lokomat

Device

Robotic-assisted walking device

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)

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Sep 11, 2009
Registry last updated: Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed