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SIRRACT: Stroke Inpatient Rehabilitation Reinforcement of ACTivity

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01246882
Collaborator
National Taiwan University Hospital (Other), Washington University School of Medicine (Other), University of Vigo (Other), Morinomiya Hospital, Osaka, Japan (Other), Mayo Clinic (Other), IRCCS San Camillo, Venezia, Italy (Other), Fairlawn Hospital, Worcester, MA, USA (Other), Chonnam National University Hospital (Other), Ain Shams University (Other), MedStar National Rehabilitation Network (Other), St. Luke's Hospital, Pennsylvania (Other), Father Muller Medical College (Other), Burke Rehabilitation Hospital (Other), Burwood Hospital, Christchurch, New Zealand (Other), Gazi University (Other), University College Hospital, Ibadan, Nigeria (Other), Rehabilitation Hospital, Barcelona, Spain (Other), IRCCS San Raffaele (Other)
140
Enrollment
18
Locations
2
Arms
22
Duration (Months)
7.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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
  • Behavioral: Augmented activity feedback
  • Behavioral: Speed-only feedback
 Phase 3

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
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 :
Jan 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

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 [Discharge]

    Secondary Outcome Measures

    1. Distance walked in 3 minutes [Discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Fairlawn Hospital Worcester Massachusetts United States 01602
    2 Mayo Clinic Rochester Minnesota United States 55905
    3 Washington University Saint Louis Missouri United States 63108
    4 Burke Rehabilitation Hospital White Plains New York United States 10605
    5 St. Luke's Hospital Allentown Pennsylvania United States 18104
    6 Ain Shams University Cairo Egypt
    7 Father Muller Medical College Karnataka India
    8 National Rehabilitation Hospital Dublin Ireland
    9 San Raffaele Hospital Milan Italy
    10 Sam Camillo Venice Italy
    11 Morinomiya Hospital Osaka Japan
    12 Chonnam National Hospital Gwangju Korea, Republic of
    13 Burwood Hospital Christchurch New Zealand
    14 Univeristy College Hospital Ibadan Nigeria
    15 Rehabilitation Hospital Barcelona Spain
    16 University of Vigo Vigo Spain
    17 National Taiwan University Hospital Taipei Taiwan
    18 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 College Hospital, Ibadan, Nigeria
    • Rehabilitation Hospital, Barcelona, Spain
    • IRCCS San Raffaele

    Investigators

    • Principal Investigator: Bruce H Dobkin, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bruce H. Dobkin, Professor, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT01246882
    Other Study ID Numbers:
    • 10-000134
    First Posted:
    Nov 23, 2010
    Last Update Posted:
    May 1, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Bruce H. Dobkin, Professor, University of California, Los Angeles
    Stroke, gait, walking, disability
    wireless inertial sensing
    mobile health
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of May 1, 2019