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Smartphone Feedback for Physical Activity in Spinal Cord Injury

Phase 2
Recruiting
Led By Shivayogi V Hiremath, PhD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Awards & highlights

Summary

This trial is studying an intervention that uses a sensor to detect physical activity and then gives feedback to help people with spinal cord injuries be more active.

Who is the study for?
This trial is for individuals aged 18-75 with spinal cord injury at C5 level or below, who are at least 6 months post-injury. They must primarily use a wheelchair and be able to exercise using their arms. Participants should be ready for physical activity and experienced in using smartphones and smartwatches. Those with medical conditions restricting activity or traumatic brain injury cannot join.
What is being tested?
The study tests a web-based physical activity program combined with just-in-time adaptive interventions (JITAI) delivered through smartphones to boost physical activity in people with spinal cord injuries. It aims to see if this tech-enhanced approach is more effective than the standard web-based program alone.
What are the potential side effects?
Since this trial involves non-drug interventions like information messages and goal setting via smartphone, there are no direct side effects as seen with medications; however, participants may experience fatigue or discomfort from increased physical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in moderate-intensity (or higher) physical activity
Change in proximal physical activity
Self-reported change in moderate-intensity (or higher) leisure time physical activity
+1 more
Secondary study objectives
Fatigue level
Pain level number
Pain level type
Other study objectives
Age
American Spinal Injury Association Impairment Scale (AIS)
Assistive or Mobility device use
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)Experimental Treatment9 Interventions
Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.
Group II: Web-based physical activity intervention (WI) programActive Control3 Interventions
Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).

Find a Location

Who is running the clinical trial?

Good Shepherd Rehabilitation NetworkOTHER
1 Previous Clinical Trials
62 Total Patients Enrolled
University of MichiganOTHER
1,833 Previous Clinical Trials
6,422,932 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,638 Total Patients Enrolled

Media Library

JITAI physical activity message Clinical Trial Eligibility Overview. Trial Name: NCT05317832 — Phase 2
Spinal Cord Injury Research Study Groups: Web-based physical activity intervention (WI) program, Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)
Spinal Cord Injury Clinical Trial 2023: JITAI physical activity message Highlights & Side Effects. Trial Name: NCT05317832 — Phase 2
JITAI physical activity message 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317832 — Phase 2
~104 spots leftby Mar 2026
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