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Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury

Recruiting
18-75 years
All
Phase 2

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Overview

The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain physical activity levels among individuals with spinal cord injury (SCI) in their communities. A primary objective of this study is to evaluate the integration of a JITAI with a web-based physical activity intervention program. We hypothesize that the integration of web-based physical activity intervention program with JITAI will result in significantly higher physical activity levels compared to the standard web-based physical activity intervention program alone. A secondary objective of this study is to extend existing algorithms that use commercial wearable technology to robustly detect physical activity behaviors to facilitate the delivery of tailored just-in-time actionable feedback and physical activity recommendations for individuals with SCI.

Description

The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.

Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone.

Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity.

Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue.

The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life.

Eligibility

Inclusion Criteria: Participants with SCI will be included if they are:

  • 18-75 years of age
  • have a traumatic or non-traumatic SCI (classification of neurological level of injury at cervical level 5 (C5) and below)
  • are at least 6-months post-SCI
  • use a manual or a power wheelchair as their primary means of mobility (>80% of time)
  • can use their arms to exercise
  • show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire
  • have experience using a smartphone and smartwatch.

Exclusion Criteria: Participants will be excluded if they have:

  • any secondary complications that medically restrict their activity in any way such as cardiovascular disease, pressure injuries, contractures, and infections
  • are diagnosed with traumatic brain injury.

Study details
    Spinal Cord Injuries

NCT05317832

Temple University

1 November 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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