Improving Ambulation Post Stroke With Robotic Training

NCT ID: NCT00975156

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-10-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lokomat Intervention

Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).

Group Type: EXPERIMENTAL

Lokomat

Intervention Type: DEVICE

Robotic-assisted walking device

Standard of Care

Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Conventional physical therapy

Interventions

Physical Therapy

Conventional physical therapy

Intervention Type: OTHER

Lokomat

Robotic-assisted walking device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Noser

Clinical Assistant Professor - Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Noser, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann

Houston, Texas, United States

Countries

United States

Other Identifiers

Medallion Grant

Identifier Type: -

Identifier Source: secondary_id

HSC-MH-08-0206

Identifier Type: -

Identifier Source: org_study_id