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 Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Lokomat; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Elizabeth Noser, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (Estimate): September 11, 2009

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-MH-08-0206; Medallion Grant