Trial record 1 of 2 for:    SIRRACT
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Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT)

This study has been completed.
Sponsor:
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
MedStar National Rehabilitation Network
St. Luke's Hospital, Pennsylvania
Father Muller Medical College
Burke Rehabilitation Hospital
Burwood Hospital, Christchurch, New Zealand
Gazi University
University of Ibadan
Rehabilitation Hospital, Barcelona, Spain
IRCCS San Raffaele
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
  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:
  • accelerometry
  • hemiparetic stroke
  • mobile health
  • wireless health
  • feedback about performance
  • physical therapy for stroke rehabilitation
  • locomotion
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
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: 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
MedStar National Rehabilitation Network
St. Luke's Hospital, Pennsylvania
Father Muller Medical College
Burke Rehabilitation Hospital
Burwood Hospital, Christchurch, New Zealand
Gazi University
University of Ibadan
Rehabilitation Hospital, Barcelona, Spain
IRCCS San Raffaele
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 July 31, 2014