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Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT)

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.
ClinicalTrials.gov Identifier: NCT01246882
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Behavioral: Augmented activity feedback Behavioral: Speed-only feedback Phase 2

Detailed Description:
Wireless Sensor System The inertial sensor system and activity-recognition algorithms were previously described and tested for short-term reliability. Three sets of triaxial accelerometers (Gulf Coast Data Concepts, Waveland, MS) were mailed to each site's coordinator. Therapists placed one sensor on each ankle before participants got out of bed each morning and removed them once they were in bed at the end of the day; sensor use during weekends was optional. A soft snap band secured each sensor proximal to the medial malleolus, flush against the bony tibia. Every night, sensors were plugged into a local computer to recharge while accelerometer data were uploaded to the central server at UCLA for secure storage and processing. Sensor Calibration and Data Processing In recognition of the variations in gait speed and stand and swing symmetry that occur in patients who need inpatient rehabilitation after stroke, we chose to generate individual templates of each participant's gait from a pair of standardized walks. On study entry participants performed two stopwatch- timed 10-meter walks at self-selected casual and safest fast walking speeds. A hybrid classifier employing dynamic time warping and Naïve Bayes algorithms generated statistical models of each participant's gait based on the two walks. Repeat walks were performed and the templates updated weekly for the remainder of each participant's rehabilitation stay to account for expected changes in gait parameters.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial
Study Start Date : January 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Augmented activity feedback
Feedback three times per week about 10-m walking speed, plus amount and types of physical activity measured using wireless bilateral ankle sensors that detect bouts of walking and cycling speed, duration, and distance.
Behavioral: Augmented activity feedback
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
Feedback three times per week about overground walking speed over 10 meters.
Behavioral: Speed-only feedback
Feedback about walking speed will be provided 3 times per week.

Outcome Measures

Primary Outcome Measures :
  1. Gait speed [ Time Frame: Discharge ]

Secondary Outcome Measures :
  1. Distance walked in 3 minutes [ Time Frame: Discharge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01246882

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
Saint 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
Ain Shams University
Cairo, Egypt
Father Muller Medical College
Karnataka, India
National Rehabilitation Hospital
Dublin, Ireland
San Raffaele Hospital
Milan, Italy
Sam Camillo
Venice, Italy
Morinomiya Hospital
Osaka, Japan
Korea, Republic of
Chonnam National Hospital
Gwangju, Korea, Republic of
New Zealand
Burwood Hospital
Christchurch, New Zealand
Univeristy College Hospital
Ibadan, Nigeria
Rehabilitation Hospital
Barcelona, Spain
University of Vigo
Vigo, Spain
National Taiwan University Hospital
Taipei, Taiwan
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
Principal Investigator: Bruce H Dobkin, MD University of California, Los Angeles
More Information

Responsible Party: Bruce H. Dobkin, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01246882     History of Changes
Other Study ID Numbers: 10-000134
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Bruce H. Dobkin, University of California, Los Angeles:
Stroke, gait, walking, disability
wireless inertial sensing
mobile health

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
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