Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT)
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborators:
National Taiwan University Hospital
Washington University School of Medicine
University of Vigo
Morinomiya Hospital, Osaka, Japan
Mayo Clinic
IRCCS San Camillo, Venezia, Italy
Fairlawn Hospital, Worcester, MA, USA
Chonnam National University Hospital
Ain Shams University
National Rehabilitation Hospital
St. Luke's Hospital, Pennsylvania
Father Muller Medical College
Burke Rehabilitation Hospital
Burwood Hospital, Christchurch, New Zealand
Gazi University
University College Hospital, Ibadan, Nigeria
Rehabilitation Hospital, Barcelona, Spain
IRCSS San Raffaele, Milan, Italy
Information provided by (Responsible Party):
Bruce H. Dobkin, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01246882
First received: November 22, 2010
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine the effects of daily feedback about physical activity (number of bouts of walking, duration of bouts, total walking distance, average and fastest walking speed) and walking average speed compared to feedback about walking speed only on walking-related outcomes during inpatient rehabilitation for stroke. For the first time, daily walking and other exercise will be monitored by bilateral triaxial accelerometers on the ankles. Activity-recognition algorithms will analyze the inpatient sensor data and return a summary to the participants at each site.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Behavioral: wireless sensor monitoring of walking-related physical therapy Behavioral: Speed-only feedback |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Gait speed [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Distance walked in 3 minutes [ Time Frame: Discharge ] [ Designated as safety issue: No ]
| Enrollment: | 140 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Feedback about walking speed plus activity
Participants will receive feedback three times per week about walking speed and amount and types of physical activity measured using wireless bilateral ankle sensors to detect bouts of walking, including speed, duration, and distance.
|
Behavioral: wireless sensor monitoring of walking-related physical therapy
Feedback about walking speed and amount of physical activity will be provided 3 times per week from data acquired from wireless sensors on each ankle.
Other Names:
|
|
Active Comparator: Speed only feedback
Participants will receive feedback three times per week about walking speed.
|
Behavioral: Speed-only feedback
Feedback about walking speed will be provided 3 times per week.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Admission for acute inpatient rehabilitation of a first stroke (or second stroke after full recovery from prior TIA/Stroke)
- Time from onset of stroke to admission for rehabilitation < 35 days
- Stroke from any cause (thrombotic infarct, cardioembolus, intracerebral hemorrhage) that includes unilateral hemiparesis. Hemiparesis means less than / equal to 4/5 strength by the British Medical Council scale for hip flexion tested supine and for knee or ankle flexion and extension (scores less than / equal to 22 of 25 possible points)
- Ability to follow simple instructions, especially to understand verbal reinforcement about activity.
- Independent in mobility prior to admission by the Barthel Index.
- Able to walk with no more than physical assistance of 2 persons for at least 5 steps (for example, 3 strides of the left leg alternating with 2 on the right leg). Subjects can use any type of assistive device and brace needed.
- Able to understand and repeat information related to the Informed Consent. The subject signs a Consent form.
Exclusion Criteria:
- Current medical disease that will limit physical therapy at the time of randomization or limited walking prior to the stroke, such as serious infection, DVT, orthostatic hypotension, > stage 2 decubitus ulcer of buttocks or legs, congestive heart failure, claudication, and pain with weight-bearing or walking. Subjects can be entered if a complication resolves within 7 days of admission screening.
- Aphasia with inability to follow 2-step directions during therapeutic instructions or answers Yes/No to questions with < 75% accuracy related to personal health and symptoms.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246882
Locations
| United States, Massachusetts | |
| Fairlawn Hospital | |
| Worcester, Massachusetts, United States, 01602 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63108 | |
| United States, New York | |
| Burke Rehabilitation Hospital | |
| White Plains, New York, United States, 10605 | |
| United States, Pennsylvania | |
| St. Luke's Hospital | |
| Allentown, Pennsylvania, United States, 18104 | |
| Egypt | |
| Ain Shams University | |
| Cairo, Egypt | |
| India | |
| Father Muller Medical College | |
| Karnataka, India | |
| Ireland | |
| National Rehabilitation Hospital | |
| Dublin, Ireland | |
| Italy | |
| San Raffaele Hospital | |
| Milan, Italy | |
| Sam Camillo | |
| Venice, Italy | |
| Japan | |
| Morinomiya Hospital | |
| Osaka, Japan | |
| Korea, Republic of | |
| Chonnam National Hospital | |
| Gwangju, Korea, Republic of | |
| New Zealand | |
| Burwood Hospital | |
| Christchurch, New Zealand | |
| Nigeria | |
| Univeristy College Hospital | |
| Ibadan, Nigeria | |
| Spain | |
| Rehabilitation Hospital | |
| Barcelona, Spain | |
| University of Vigo | |
| Vigo, Spain | |
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Turkey | |
| Gazi University | |
| Ankara, Turkey | |
Sponsors and Collaborators
University of California, Los Angeles
National Taiwan University Hospital
Washington University School of Medicine
University of Vigo
Morinomiya Hospital, Osaka, Japan
Mayo Clinic
IRCCS San Camillo, Venezia, Italy
Fairlawn Hospital, Worcester, MA, USA
Chonnam National University Hospital
Ain Shams University
National Rehabilitation Hospital
St. Luke's Hospital, Pennsylvania
Father Muller Medical College
Burke Rehabilitation Hospital
Burwood Hospital, Christchurch, New Zealand
Gazi University
University College Hospital, Ibadan, Nigeria
Rehabilitation Hospital, Barcelona, Spain
IRCSS San Raffaele, Milan, Italy
Investigators
| Principal Investigator: | Bruce H Dobkin, MD | University of California, Los Angeles |
More Information
Publications:
| Responsible Party: | Bruce H. Dobkin, Professor, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01246882 History of Changes |
| Other Study ID Numbers: | 10-000134 |
| Study First Received: | November 22, 2010 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
Stroke, gait, walking, disability |
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 |
ClinicalTrials.gov processed this record on May 23, 2013