Improving physical activity for individuals with spinal cord injury using smartphones
mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
This study is testing if using a smartphone app that gives personalized feedback can help people with spinal cord injuries be more active compared to a regular online program.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Temple University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05317832 on ClinicalTrials.gov |
What this trial studies
This research evaluates a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy aimed at increasing and sustaining physical activity levels among individuals with spinal cord injuries (SCI). Participants will be randomized into two groups: one receiving a standard web-based physical activity intervention and the other receiving the same intervention combined with JITAI, which provides tailored feedback based on real-time physical activity data. The study will also utilize a micro-randomized trial design to optimize the delivery of feedback and recommendations, while investigating various moderators that may affect outcomes. The goal is to determine if the integration of JITAI leads to significantly higher physical activity levels compared to the standard intervention alone.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with a spinal cord injury classified at cervical level 5 and below, who primarily use a wheelchair and are ready to engage in physical activity.
Not a fit: Patients with secondary complications that restrict their activity or those diagnosed with traumatic brain injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance physical activity levels and overall quality of life for individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar just-in-time adaptive interventions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania
- Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Shivayogi V Hiremath, PhD — Temple University
- Study coordinator: Shivayogi V Hiremath, PhD
- Email: shiv.hiremath@temple.edu
- Phone: 2152040496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.