Walking Study for Stroke Rehabilitation (SIRROWS)

This study has been completed.
Sponsor:
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
Rehabilitation Institute of Chicago
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
ClinicalTrials.gov Identifier:
NCT00428480
First received: January 29, 2007
Last updated: November 10, 2011
Last verified: July 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Rehabilitation Institute of Chicago
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

No publications provided

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
Study First Received: January 29, 2007
Last Updated: November 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014