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Stroke Inpatient Rehabilitation Reinforcement of ACTivity (SIRRACT)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Augmented activity feedback
Speed-only feedback
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, gait, walking, disability, wireless inertial sensing, mobile health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fairlawn Hospital
  • Mayo Clinic
  • Washington University
  • Burke Rehabilitation Hospital
  • St. Luke's Hospital
  • Ain Shams University
  • Father Muller Medical College
  • National Rehabilitation Hospital
  • San Raffaele Hospital
  • Sam Camillo
  • Morinomiya Hospital
  • Chonnam National Hospital
  • Burwood Hospital
  • Univeristy College Hospital
  • Rehabilitation Hospital
  • University of Vigo
  • National Taiwan University Hospital
  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Augmented activity feedback

speed-only feedback

Arm Description

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.

Feedback three times per week about overground walking speed over 10 meters.

Outcomes

Primary Outcome Measures

Gait speed

Secondary Outcome Measures

Distance walked in 3 minutes

Full Information

First Posted
November 22, 2010
Last Updated
April 29, 2019
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, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01246882
Brief Title
Stroke Inpatient Rehabilitation Reinforcement of ACTivity
Acronym
SIRRACT
Official Title
Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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, 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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, gait, walking, disability, wireless inertial sensing, mobile health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Augmented activity feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
speed-only feedback
Arm Type
Active Comparator
Arm Description
Feedback three times per week about overground walking speed over 10 meters.
Intervention Type
Behavioral
Intervention Name(s)
Augmented activity feedback
Other Intervention Name(s)
accelerometry, hemiparetic stroke, mobile health, wireless health, feedback about performance, physical therapy for stroke rehabilitation, locomotion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speed-only feedback
Intervention Description
Feedback about walking speed will be provided 3 times per week.
Primary Outcome Measure Information:
Title
Gait speed
Time Frame
Discharge
Secondary Outcome Measure Information:
Title
Distance walked in 3 minutes
Time Frame
Discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce H Dobkin, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairlawn Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01602
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
St. Luke's Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Facility Name
Father Muller Medical College
City
Karnataka
Country
India
Facility Name
National Rehabilitation Hospital
City
Dublin
Country
Ireland
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy
Facility Name
Sam Camillo
City
Venice
Country
Italy
Facility Name
Morinomiya Hospital
City
Osaka
Country
Japan
Facility Name
Chonnam National Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Burwood Hospital
City
Christchurch
Country
New Zealand
Facility Name
Univeristy College Hospital
City
Ibadan
Country
Nigeria
Facility Name
Rehabilitation Hospital
City
Barcelona
Country
Spain
Facility Name
University of Vigo
City
Vigo
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Gazi University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21989632
Citation
Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.
Results Reference
background
PubMed Identifier
25261154
Citation
Dorsch AK, Thomas S, Xu X, Kaiser W, Dobkin BH; SIRRACT investigators. SIRRACT: An International Randomized Clinical Trial of Activity Feedback During Inpatient Stroke Rehabilitation Enabled by Wireless Sensing. Neurorehabil Neural Repair. 2015 Jun;29(5):407-15. doi: 10.1177/1545968314550369. Epub 2014 Sep 26.
Results Reference
result

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Stroke Inpatient Rehabilitation Reinforcement of ACTivity

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