Walking Study for Stroke Rehabilitation - Full Text View

Walking Study for Stroke Rehabilitation (SIRROWS)

This study is currently recruiting participants.

Verified by University of California, Los Angeles, June 2008

Sponsors and Collaborators:	University of California, Los Angeles WORLD FEDERATION FOR NEUROREHABILITATION Mayo Clinic Rehabilitation Unit, Fondazione Instituto San Raffaele-Giglio, Italy University of Vigo Morinomia Hospital, Osaka, Japan Chonnam National University Hospital Asklepios Klinik Burke Rehabilitation Hospital Hacettepe University Department of Rehabilitation, University Hospital, Czech Republic Federal Medical Center, Abeokuta, Nigeria Ankara University Institute for Clinical Research University of Chicago Helen Hays Hospital, NY, USA Gazi University All India Institute of Medical Sciences, New Delhi Rehabilitation Institute of Chicago St. Luke's Hospital, Pennsylvania Hospital Hochzirl, Zirl, Austria Father Muller Medical College Kernan Hospital, Baltimore IRCCS San Camillo, Venezia, Italy Kessler Medical Rehabilitation Research Center Vanderbilt Stallworth Rehabilitation Hospital, TN Rehabilitation Hospital of Rhode Island, RI St. Mauritius Therapieklinik, Dusseldort, Germany
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00428480

Purpose

The primary purpose of this study is to determine the effects of reinforcement of walking speed on recovery of walking speed over the course of inpatient rehabilitation for people after stroke. The study will also examine the relationship between short distance walking speed and walking distance over a fixed time.

Condition	Intervention	Phase
Stroke	Behavioral: Daily reinforcement of walking speed (DRS) Behavioral: No reinforcement of walking speed (NRS)	Phase I

MedlinePlus related topics: Methamphetamine Rehabilitation

Drug Information available for: Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Stroke Inpatient Rehabilitation Reinforcement of Walking Speed

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Gait speed [ Time Frame: Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Distance walked in 3 minutes [ Time Frame: 4 weeks, discharge, 3 months, 6 months ] [ Designated as safety issue: No ]
Functional Ambulation Classification (FAC) [ Time Frame: Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months ] [ Designated as safety issue: Yes ]
Number of falls post inpatient rehabilitation [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Daily reinforcement of walking speed	Behavioral: Daily reinforcement of walking speed (DRS) Inpatients are encouraged to walk faster and given feedback on their walking speed during a daily 10-meter walk as part of their usual physical therapy.
2: Active Comparator No reinforcement of walking speed	Behavioral: No reinforcement of walking speed (NRS) Inpatients complete a 10-meter walk as part of their daily physical therapy but are not given any encouragement to walk faster or feedback on their walking speed.

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Eligibility

Ages Eligible for Study:	35 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

35 years or older
suffered a stroke from any cause that is unlikely to progress or recur within 2 years of onset (thrombotic infarct, cardioembolus, intracerebral hemorrhage)
unilateral hemiparesis with strength of the proximal leg muscles ≤4/5
able to follow simple instructions and understand verbal reinforcement about walking speed
able to take 5 steps with not more than the assistance of one person

Exclusion Criteria:

premorbid walking difficulty in the community, such as a prior stroke with residual impairment, arthritis with pain on stepping, dyspnea or angina on modest exertion, limited walking endurance due to cardiopulmonary or other disease
history of dementia
current medical disease that will limit physical therapy at the time of randomization, such as critical illness myopathy/neuropathy, serious infection, thrombophlebitis, orthostatic hypertension, decubitus ulcer, congestive heart failure, chronic obstructive lung disease, organ transplantation, recent surgery (including coronary bypass), or pain with weigh bearing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428480

Contacts

Contact: Bruce H Dobkin, MD	310-206-6500	bdobkin@mednet.ucla.edu
Contact: Prudence Plummer D'Amato, PhD	310-794-1461	pdamato@ucla.edu

Show 24 Study Locations

Sponsors and Collaborators

University of California, Los Angeles

WORLD FEDERATION FOR NEUROREHABILITATION

Mayo Clinic

Rehabilitation Unit, Fondazione Instituto San Raffaele-Giglio, Italy

University of Vigo

Morinomia Hospital, Osaka, Japan

Chonnam National University Hospital

Asklepios Klinik

Burke Rehabilitation Hospital

Hacettepe University

Department of Rehabilitation, University Hospital, Czech Republic

Federal Medical Center, Abeokuta, Nigeria

Ankara University

Institute for Clinical Research

University of Chicago

Helen Hays Hospital, NY, USA

Gazi University

All India Institute of Medical Sciences, New Delhi

Rehabilitation Institute of Chicago

St. Luke's Hospital, Pennsylvania

Hospital Hochzirl, Zirl, Austria

Father Muller Medical College

Kernan Hospital, Baltimore

IRCCS San Camillo, Venezia, Italy

Kessler Medical Rehabilitation Research Center

Vanderbilt Stallworth Rehabilitation Hospital, TN

Rehabilitation Hospital of Rhode Island, RI

St. Mauritius Therapieklinik, Dusseldort, Germany

Investigators

Principal Investigator:

Bruce H Dobkin, MD

University of California, Los Angeles

More Information

Responsible Party:	University of California Los Angeles ( Dr. Bruce Dobkin )
Study ID Numbers:	UCLA-06-07-104-01
Study First Received:	January 29, 2007
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00428480
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Methamphetamine
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Amphetamine
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009