Improving Ambulation Post Stroke With Robotic Training

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Physical Therapy; Device: Lokomat

• Registration Number: NCT00975156
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Results First Submitted: 2012-08-14
• Results First Submitted QC: 2012-08-14
• Results First Posted: 2012-09-13
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Physical Therapy	Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.
Lokomat Intervention	Lokomat	Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).

Primary Outcome Measures

Name	Time	Method
10-meter Walking Test (10mWT)	Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Hermann; 🇺🇸 Houston, Texas, United States