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Trial record 1 of 1 for:    SIRROWS
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Walking Study for Stroke Rehabilitation (SIRROWS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428480
First Posted: January 30, 2007
Last Update Posted: November 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
WORLD FEDERATION FOR NEUROREHABILITATION
Mayo Clinic
The Foundation Institute San Raffaele G. Giglio of Cefalù
University of Vigo
Morinomiya Hospital, Osaka, Japan
Chonnam National University Hospital
Asklepios Kliniken Hamburg GmbH
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 Hayes Hospital
Gazi University
All India Institute of Medical Sciences, New Delhi
Shirley Ryan AbilityLab
St. Luke's Hospital, Pennsylvania
Hochzirl Hospital
Father Muller Medical College
Kernan Hospital, Baltimore
IRCCS San Camillo, Venezia, Italy
Kessler Foundation
Vanderbilt Stallworth Rehabilitation Hospital, TN
Rehabilitation Hospital of Rhode Island, RI
St. Mauritius Therapieklinik, Dusseldort, Germany
Information provided by:
University of California, Los Angeles
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Inpatient Rehabilitation Reinforcement of Walking Speed

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Distance walked in 3 minutes [ Time Frame: 4 weeks, discharge, 3 months, 6 months ]
  • Functional Ambulation Classification (FAC) [ Time Frame: Admission, 2 weeks, 4 weeks, 6 weeks, 8 weeks, discharge, 3 months, 6 months ]
  • Number of falls post inpatient rehabilitation [ Time Frame: 3 months, 6 months ]

Enrollment: 216
Study Start Date: May 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: DRS
Active Comparator: 2
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.
Other Name: NRS

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428480


  Show 24 Study Locations
Sponsors and Collaborators
University of California, Los Angeles
WORLD FEDERATION FOR NEUROREHABILITATION
Mayo Clinic
The Foundation Institute San Raffaele G. Giglio of Cefalù
University of Vigo
Morinomiya Hospital, Osaka, Japan
Chonnam National University Hospital
Asklepios Kliniken Hamburg GmbH
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 Hayes Hospital
Gazi University
All India Institute of Medical Sciences, New Delhi
Shirley Ryan AbilityLab
St. Luke's Hospital, Pennsylvania
Hochzirl Hospital
Father Muller Medical College
Kernan Hospital, Baltimore
IRCCS San Camillo, Venezia, Italy
Kessler Foundation
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: Dr. Bruce Dobkin, University of California Los Angeles
ClinicalTrials.gov Identifier: NCT00428480     History of Changes
Other Study ID Numbers: UCLA-06-07-104-01
First Submitted: January 29, 2007
First Posted: January 30, 2007
Last Update Posted: November 11, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors