Spinal Cord Injuries Clinical Trial
Official title:
mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
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.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | June 30, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Temple University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Albert Einstein Healthcare Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Magee Rehabilitation Hospital, Jefferson Health, Northeastern University, Thomas Jefferson University, University of Alabama at Birmingham, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical activity recommendations from JITAI | The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the WI program. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application. | WI Program (weeks 2-16) | |
Other | Physical activity recommendations from JITAI | The study will assess if physical activity recommendations from JITAI will lead to (on average) more days of aerobic and strength exercises per week during the physical activity sustainability. The information whether the participants performed their aerobic and strength exercises will be assessed through an ecological momentary assessment from the mobile-health application. | Physical activity sustainability (weeks 17-24) | |
Other | Feedback about physical activity levels from JITAI | The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the WI program. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch). | WI Program (weeks 2-16) | |
Other | Feedback about physical activity levels from JITAI | The study will assess if feedback about their physical activity levels from JITAI will lead to (on average) more minutes of aerobic exercise during the physical activity sustainability. The information whether the participants performed more aerobic exercise will be measured via mobile-health sensor (smartwatch). | physical activity sustainability (weeks 17-24) | |
Other | Age | Age will be assessed as a moderator for Aim 3. | Baseline (week 0) | |
Other | Sex | Biological sex will be examined as a potential time-invariant moderator for Aim 3. | Baseline (week 0) | |
Other | Race/ethnicity | Race/ethnicity will be examined as a potential time-invariant moderator for Aim 3. | Baseline (week 0) | |
Other | American Spinal Injury Association Impairment Scale (AIS) | SCI impairment will be assessed using the American Spinal Injury Association Impairment scale (AIS) from the American Spinal Injury Association. | Baseline (week 0) | |
Other | SCI and level of injury | SCI and level of injury will be assessed using the SCI Spinal Column Injury Basic Data Set Form. | Baseline (week 0) | |
Other | Non-traumatic SCI | Non-traumatic SCI will be assessed using the Non-traumatic SCI Data set Version 1.0 Form. | Baseline (week 0) | |
Other | Functional level of participants | Spinal Cord Independence Measure version III (SCIM III) survey will be used to measure the functional levels of participants. The functional levels of participants is assessed through performance in activities of daily living and mobility. | Baseline (week 0) | |
Other | Assistive or Mobility device use | Descriptive information about participants using an assistive technology device or mobility device will be collected through an Assistive Mobility Devices and Orthoses Form (survey). | Baseline (week 0) | |
Primary | Change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and WI program. | Baseline (week 2) and WI Program (week 16) | |
Primary | Change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via mobile-health sensor (smartwatch that is part of the just-in-time adaptive intervention system - JITAI), between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | |
Primary | Self-reported change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and WI program. | Baseline (week 2) and WI Program (week 16) | |
Primary | Self-reported change in moderate-intensity (or higher) physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Physical Activity Recall Assessment for People with Spinal Cord injury (PARA-SCI) survey, between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | |
Primary | Self-reported change in moderate-intensity (or higher) leisure time physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and WI program. | Baseline (week 2) and WI program (week 16) | |
Primary | Self-reported change in moderate-intensity (or higher) leisure time physical activity | The change in average duration of moderate-intensity (or higher) physical activity, measured via Leisure Time Physical Activity Questionnaire for People with SCI (LTPAQ-SCI) survey, between baseline and physical activity sustainability. | Baseline (week 2) and physical activity sustainability (week 24) | |
Primary | Change in proximal physical activity | The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the WI program among those who are available at the previous randomization decision point. | WI Program (week 2) and WI Program (week 16) | |
Primary | Change in proximal physical activity | The primary analysis for this study will address the question of whether, on average, the feedback and physical activity recommendations from JITAI will have a proximal effect on minutes of physical activity performed over the next 120 minutes during the physical activity sustainability among those who are available at the previous randomization decision point. | Physical activity sustainability (week 17) and Physical activity sustainability (week 24) | |
Secondary | Pain level number | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the pain level (number) in the participants over the course of the study. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | |
Secondary | Pain level type | The International SCI Pain Basic Data Set Version 2.0 form will allow us to collect the types of pain (nociceptive, neuropathic, and other) in the participants over the course of the study. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) | |
Secondary | Fatigue level | The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level. | Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24) |
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