Stroke Inpatient Rehabilitation Reinforcement of ACTivity

Stroke Clinical Trial

— SIRRACT  

Official title:

Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246882
• Other study ID #: 10-000134
• Status: Completed
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Speed-only feedback
Feedback about walking speed will be provided 3 times per week.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo
India	Father Muller Medical College	Karnataka
Ireland	National Rehabilitation Hospital	Dublin
Italy	San Raffaele Hospital	Milan
Italy	Sam Camillo	Venice
Japan	Morinomiya Hospital	Osaka
Korea, Republic of	Chonnam National Hospital	Gwangju
New Zealand	Burwood Hospital	Christchurch
Nigeria	Univeristy College Hospital	Ibadan
Spain	Rehabilitation Hospital	Barcelona
Spain	University of Vigo	Vigo
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Gazi University	Ankara
United States	St. Luke's Hospital	Allentown	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Burke Rehabilitation Hospital	White Plains	New York
United States	Fairlawn Hospital	Worcester	Massachusetts

Sponsors (19)

Lead Sponsor

Collaborator

University of California, Los Angeles

Ain Shams University, Burke Rehabilitation Hospital, Burwood Hospital, Christchurch, New Zealand, Chonnam National University Hospital, Fairlawn Hospital, Worcester, MA, USA, Father Muller Medical College, Gazi University, IRCCS San Camillo, Venezia, Italy, IRCCS San Raffaele, Mayo Clinic, MedStar National Rehabilitation Network, Morinomiya Hospital, Osaka, Japan, National Taiwan University Hospital, Rehabilitation Hospital, Barcelona, Spain, St. Luke's Hospital, Pennsylvania, University College Hospital, Ibadan, Nigeria, University of Vigo, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Egypt,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Nigeria,  Spain,  Taiwan,  Turkey, 

References & Publications (2)

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. Review. — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed		Discharge
Secondary	Distance walked in 3 minutes		Discharge