Walking Study for Stroke Rehabilitation (SIRROWS)
This study has been completed.
Sponsor:
University of California, Los Angeles
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 Hays 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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428480
Show 24 Study Locations
Show 24 Study LocationsSponsors 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 Hays 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:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Amphetamine Methamphetamine Central Nervous System Stimulants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013