NCT05317832 Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
| NCT ID | NCT05317832 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Temple University |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 196 participants in total. It began in 2023-05-25 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Shivayogi V Hiremath, PhD
PRINCIPAL INVESTIGATOR
Temple University
Frequently Asked Questions
Who can join the NCT05317832 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05317832 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05317832 currently recruiting?
Yes, NCT05317832 is actively recruiting participants. Contact the research team at shiv.hiremath@temple.edu for enrollment information.
Where is the NCT05317832 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05317832 clinical trial?
NCT05317832 is sponsored by Temple University. The principal investigator is Shivayogi V Hiremath, PhD at Temple University. The trial plans to enroll 196 participants.