RecruitingPhase 2

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

United States196 participantsStarted 2023-05-25

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and WI Program (week 16)

Change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)

Self-reported change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and WI Program (week 16)

Self-reported change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)

Self-reported change in moderate-intensity (or higher) leisure time physical activity

Timeframe: Baseline (week 2) and WI program (week 16)

Self-reported change in moderate-intensity (or higher) leisure time physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)

Trial details

NCT IDNCT05317832

SponsorTemple University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Shivayogi V Hiremath, PhD

2152040496 shiv.hiremath@temple.edu

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and WI Program (week 16)

Change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)

Self-reported change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and WI Program (week 16)

Self-reported change in moderate-intensity (or higher) physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)

Self-reported change in moderate-intensity (or higher) leisure time physical activity

Timeframe: Baseline (week 2) and WI program (week 16)

Self-reported change in moderate-intensity (or higher) leisure time physical activity

Timeframe: Baseline (week 2) and physical activity sustainability (week 24)