Clinical trial NCT00975156: Improving Ambulation Post Stroke With Robotic Training
Official title: Improving Ambulation Post Stroke With Robotic Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 10-meter Walking Test (10mWT)
timeFrame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Secondary outcomes:
measure: 6 Minute Walking Distance (6MWD)
timeFrame: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Elizabeth Noser, MD
role: PRINCIPAL_INVESTIGATOR
References: