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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||May 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Lokomat Intervention
Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975156
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elizabeth Noser, MD||The University of Texas Health Science Center, Houston|