Clinical trial NCT01246882: Stroke Inpatient Rehabilitation Reinforcement of ACTivity
Official title: Stroke Inpatient Rehabilitation Reinforcement of ACTivty: An International Multisite Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: Stroke, gait, walking, disability
wireless inertial sensing
mobile health
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Washington University School of Medicine
name: University of Vigo
name: Morinomiya Hospital, Osaka, Japan
name: Mayo Clinic
name: IRCCS San Camillo, Venezia, Italy
name: Fairlawn Hospital, Worcester, MA, USA
name: Chonnam National University Hospital
name: Ain Shams University
name: MedStar National Rehabilitation Network
name: St. Luke's Hospital, Pennsylvania
name: Father Muller Medical College
name: Burke Rehabilitation Hospital
name: Burwood Hospital, Christchurch, New Zealand
name: Gazi University
name: University College Hospital, Ibadan, Nigeria
name: Rehabilitation Hospital, Barcelona, Spain
name: IRCCS San Raffaele
First posted: 2010-11-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gait speed
timeFrame: Discharge
Secondary outcomes:
measure: Distance walked in 3 minutes
timeFrame: Discharge
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Fairlawn Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
city: Allentown
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Cairo
country: Egypt
facility: Ain Shams University
city: Karnataka
country: India
facility: Father Muller Medical College
city: Dublin
country: Ireland
facility: National Rehabilitation Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Venice
country: Italy
facility: Sam Camillo
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National Hospital
city: Christchurch
country: New Zealand
facility: Burwood Hospital
city: Ibadan
country: Nigeria
facility: Univeristy College Hospital
city: Barcelona
country: Spain
facility: Rehabilitation Hospital
city: Vigo
country: Spain
facility: University of Vigo
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: University of California, Los Angeles
name: Bruce H Dobkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.