Stroke Inpatient Rehabilitation Reinforcement of ACTivity "SIRRACT"

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Activity feedback Behavioral
    Intervention Desc: Feedback about walking speed and amount of physical activity will be provided 3 times per week from data acquired using body-worn sensors on each ankle.
    ARM 1: Kind: Experimental
    Label: Activity and speed feedback
    Description: Participants will receive feedback three times per week about walking speed and amount of physical activity (measured using activity monitoring sensors).
  • Speed feedback Behavioral
    Intervention Desc: Feedback about walking speed will be provided 3 times per week.
    ARM 1: Kind: Experimental
    Label: Speed only feedback
    Description: Participants will receive feedback three times per week about walking speed.
  • Wireless sensor monitoring of walking-related physical therapy Behavioral
    Other Names: accelerometry; hemiparetic stroke; mobile health; wireless health; feedback about performance; physical therapy for stroke rehabilitation; locomotion
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Feedback about walking speed plus activity
    Description: Participants will receive feedback three times per week about walking speed and amount and types of physical activity measured using wireless bilateral ankle sensors to detect bouts of walking, including speed, duration, and distance.
  • Speed-only feedback Behavioral
    Intervention Desc: Feedback about walking speed will be provided 3 times per week.
    ARM 1: Kind: Experimental
    Label: Speed only feedback
    Description: Participants will receive feedback three times per week about walking speed.
    ARM 2: Kind: Experimental
    Label: speed-only feedback
    Description: Feedback three times per week about overground walking speed over 10 meters.
  • Augmented activity feedback Behavioral
    Other Names: accelerometry; hemiparetic stroke; mobile health; wireless health; feedback about performance; physical therapy for stroke rehabilitation; locomotion
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Augmented activity feedback
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Gait speed Discharge No
Secondary Distance walked in 3 minutes Discharge No

Sponsors