Improving Ambulation Post Stroke With Robotic Training

NCT00975156 | Completed Results

• 2 other identifiers: HSC-MH-08-0206Medallion Grant
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 6 Minute Walking Distance (6MWD)

  Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Study Arms (2)

Lokomat Intervention

EXPERIMENTAL

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

Device: Lokomat

Standard of Care

ACTIVE COMPARATOR

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

Other: Physical Therapy

Interventions

Physical Therapy OTHER

Conventional physical therapy

Standard of Care

Lokomat DEVICE

Robotic-assisted walking device

Lokomat Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Limitations and Caveats

Limitations include: small sample (n=21 enrolled, n=20 completed) and significant (p=0.025) difference between groups in time since stroke (Lokomat group, time since stroke mean=1353.60 days; Conventional group, time since stroke mean=525.00 days).

Results Point of Contact

• Title: Elizabeth Noser
• Organization: Mischer Neuroscience Institute, Memorial Hermann-TMC

elizabeth.noser@memorialhermann.org

Study Officials

• Elizabeth Noser, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor - Neurology

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: May 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 25, 2013
• Results First Posted: September 13, 2012

Record last verified: 2013-02

Locations

US (1)