Improving Ambulation Post Stroke With Robotic Training

Stroke Clinical Trial

Official title:

Improving Ambulation Post Stroke With Robotic Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975156
• Other study ID #: HSC-MH-08-0206
• Secondary ID: Medallion Grant
• Status: Completed
• Phase: N/A
• First received: September 10, 2009
• Last updated: February 20, 2013
• Start date: May 2008
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Physical Therapy
Conventional physical therapy

Device:
• Lokomat
Robotic-assisted walking device

Locations

Country	Name	City	State
United States	Memorial Hermann	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-meter Walking Test (10mWT)		Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention	Yes
Secondary	6 Minute Walking Distance (6MWD)		Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention	Yes