Spinal Cord InjuriesPhase 2NCT05317832
Using Smartphones to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
A Phase 2 study testing WI program, WI Program Reminder and JITAI Goal Setting in people with Spinal Cord Injuries, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- WI program, WI Program Reminder and JITAI Goal Setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19121
Shivayogi V Hiremath, PhD, 215-204-0496, shiv.hiremath@temple.edu
Shivayogi V Hiremath, PhD
About this study
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.
Read the detailed description
The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone.
Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity.
Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue.
The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life.
- Conditions
- Spinal Cord Injuries
- Being tested
- WI program, WI Program Reminder, JITAI Goal Setting, JITAI physical activity message, Notification EMA
- Keywords
- spinal cord injuries, physical activity, wearable sensors, mobile health, just-in-time adaptive intervention
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WI programBehavioural
This 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features.
WI Program ReminderBehavioural
Participants will be provided with reminders to use the WI program
JITAI Goal SettingBehavioural
Participants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises.
JITAI physical activity messageBehavioural
Participants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message.
Notification EMAOther
Participants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message.
End of day EMAOther
Participants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day.
Wake up time EMAOther
Participants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day.
Weekly PA InformationOther
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days.
Daily PA InformationOther
Participants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day.
| Study group | Role | What they receive |
|---|---|---|
| Web-based physical activity intervention (WI) program | Active comparator | 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). Receives: Behavioral: WI program; Behavioral: WI Program Reminder; Other: Weekly PA Information |
| Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) | Experimental | 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. Receives: Behavioral: WI program; Behavioral: WI Program Reminder; Behavioral: JITAI Goal Setting; Behavioral: JITAI physical activity message; Other: Notification EMA; Other: End of day EMA; Other: Wake up time EMA; Other: Weekly PA Information; Other: Daily PA Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 2) and WI Program (week 16)
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.
Measured: Baseline (week 2) and physical activity sustainability (week 24)
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.
Measured: Baseline (week 2) and WI Program (week 16)
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.
Measured: Baseline (week 2) and physical activity sustainability (week 24)
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.
Measured: Baseline (week 2) and WI program (week 16)
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.
Measured: Baseline (week 2) and physical activity sustainability (week 24)
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.
Measured: WI Program (week 2) and WI Program (week 16)
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.
Measured: Physical activity sustainability (week 17) and Physical activity sustainability (week 24)
Secondary outcomes (3)
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.
Measured: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
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.
Measured: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Fatigue level
The Neuro-QOL Item Bank Version 1.0 Fatigue Short form will allow us to collect fatigue level.
Measured: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start25 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, University of Alabama at Birmingham, University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Good Shepherd Rehabilitation Network
- Responsible party
- Sponsor
- Investigators
- Shivayogi V Hiremath, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317832
- Sponsor's protocol ID
- 27338
- Other IDs
- R01HD103904
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of data generated by the proposed research study will be carried out in several different ways. We will make our results available both to the consumers with SCI and scientific community. Conversely, we would welcome collaboration with others who could make use of the information gained in this project. Temple University and its collaborators will remain Health Insurance Portability and Accountability Act (HIPAA) compliant and all data will remain free of identifiers and variables that could lead to disclosure of participant identity. During the study, preliminary analyses will be conducted at periodic intervals. Our plan is to disseminate our findings in the form of interdisciplinary peer-reviewed manuscripts and presentations at national and international conferences.
Publications
Carey RL, Le H, Coffman DL, Nahum-Shani I, Thirumalai M, Hagen C, Baehr LA, Schmidt-Read M, Lamboy MSR, Kolakowsky-Hayner SA, Marino RJ, Intille SS, Hiremath SV. mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e57699. doi: 10.2196/57699.
PubMed 38941145
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth-based Just-In-Time Adaptive Intervention to Improve Physical Activity Levels of Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05317832
- Acronym / sponsor ID
- 27338
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injuries, physical activity, wearable sensors, mobile health, just-in-time adaptive intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Northeastern University, University of Alabama at Birmingham, University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Good Shepherd Rehabilitation Network
- Study start
- 25 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The integration of the JITAI, which provides feedback and physical activity recommendations due to sensor-based assessments of physical activity, with a standard web-based physical activity intervention program will be tested via a clinical trial. Specifically, individuals with SCI will be randomized to web-based physical activity intervention program (WI) or web-based physical activity intervention program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
Aim 1: Evaluate the efficacy of the WI + JITAI compared to the standard WI alone. We hypothesize that the integration of WI + JITAI will result in significantly higher physical activity levels compared to the standard WI alone.
Aim 2: Use a micro-randomized trial design to optimize the delivery of just-in-time physical activity feedback and recommendations in promoting physical activity.
Aim 3: Investigate moderators of the effect of WI + JITAI vs. standard WI alone. Moderators will include age, gender, race/ethnicity, level of injury, function, mobility, pain, and fatigue.
The proposed study will yield novel insights about JITAIs and JITAIs combined with more traditional, WI programs, which will help researchers design engaging physical activity interventions for individuals with disability in the community that may improve their health and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The proposed study is a 24-week longitudinal study that will comprise of 2 weeks of baseline physical activity monitoring, 14 weeks of physical activity monitoring and intervention, and 8 weeks of physical activity monitoring to assess physical activity level sustainability. Individuals with SCI will be randomized to a web-based physical activity intervention (WI) program or a WI program combined with the JITAI (WI + JITAI). Within the WI + JITAI arm, a micro-randomized trial - a clinical trial design for optimizing mobile-Health interventions - will be used to randomize participants several times a day to various types of tailored feedback and physical activity recommendations.
| Arm | Type | Receives |
|---|---|---|
| Web-based physical activity intervention (WI) program | Active comparator | Behavioral: WI program, Behavioral: WI Program Reminder, Other: Weekly PA InformationParticipants 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). |
| Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) | Experimental | Behavioral: WI program, Behavioral: WI Program Reminder, Behavioral: JITAI Goal Setting, Behavioral: JITAI physical activity message, Other: Notification EMA, Other: End of day EMA, Other: Wake up time EMA, Other: Weekly PA Information, Other: Daily PA InformationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WI programThis 14-week web-based physical activity intervention (WI) program was developed by the National Center on Health, Physical Activity and Disability. The WI program was developed with guidance from literature and practice in health behavior change and internet-based health promotion programming. The content and features of the WI program include motivational resource, updated weekly resources, and customizable features. | Behavioural | Web-based physical activity intervention (WI) program, Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| WI Program ReminderParticipants will be provided with reminders to use the WI program | Behavioural | Web-based physical activity intervention (WI) program, Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| JITAI Goal SettingParticipants will be provided with standard, tailored, or no goal for the day. The goal will focus on recommending minutes of moderate-intensity (or higher) physical activity and a reminder to perform strength exercises. | Behavioural | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| JITAI physical activity messageParticipants will be provided with minutes of moderate-intensity (or higher) physical activity achieved, minutes of physical activity remaining, or no message. | Behavioural | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| Notification EMAParticipants will be inquired through an ecological momentary assessment (EMA) if they received a JITAI physical activity message. | Other | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| End of day EMAParticipants will be inquired, through an ecological momentary assessment (EMA), if they performed aerobic and/or strength exercises for the day. | Other | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| Wake up time EMAParticipants will be inquired, through an ecological momentary assessment (EMA), about the time they plan to wake up next day. This information will be used to provide a goal setting message for next day. | Other | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| Weekly PA InformationParticipants will have access to minutes of moderate-intensity (or higher) physical activity performed over the last 7 days. | Other | Web-based physical activity intervention (WI) program, Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
| Daily PA InformationParticipants will have access to minutes of moderate-intensity (or higher) physical activity performed over the day. | Other | Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) |
Primary outcome
Change in moderate-intensity (or higher) physical activity
Time frame: Baseline (week 2) and WI Program (week 16)
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.
Change in moderate-intensity (or higher) physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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.
Self-reported change in moderate-intensity (or higher) physical activity
Time frame: Baseline (week 2) and WI Program (week 16)
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.
Self-reported change in moderate-intensity (or higher) physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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.
Self-reported change in moderate-intensity (or higher) leisure time physical activity
Time frame: Baseline (week 2) and WI program (week 16)
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.
Self-reported change in moderate-intensity (or higher) leisure time physical activity
Time frame: Baseline (week 2) and physical activity sustainability (week 24)
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.
Change in proximal physical activity
Time frame: WI Program (week 2) and WI Program (week 16)
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.
Change in proximal physical activity
Time frame: Physical activity sustainability (week 17) and Physical activity sustainability (week 24)
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.
3 secondary outcomes
Pain level number
Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Pain level type
Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Fatigue level
Time frame: Baseline (weeks 0 and 2), WI Program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 38941145Carey RL, Le H, Coffman DL, Nahum-Shani I, Thirumalai M, Hagen C, Baehr LA, Schmidt-Read M, Lamboy MSR, Kolakowsky-Hayner SA, Marino RJ, Intille SS, Hiremath SV. mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 28;13:e57699. doi: 10.2196/57699.
- Individual participant dataSharing planned: Yes. Sharing of data generated by the proposed research study will be carried out in several different ways. We will make our results available both to the consumers with SCI and scientific community. Conversely, we would welcome collaboration with others who could make use of the information gained in this project. Temple University and its collaborators will remain Health Insurance Portability and Accountability Act (HIPAA) compliant and all data will remain free of identifiers and variables that could lead to disclosure of participant identity. During the study, preliminary analyses will be conducted at periodic intervals. Our plan is to disseminate our findings in the form of interdisciplinary peer-reviewed manuscripts and presentations at national and international conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shivayogi V Hiremath, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WI program, WI Program Reminder and JITAI Goal Setting in people with Spinal Cord Injuries, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivayogi V Hiremath, PhD (2152040496, shiv.hiremath@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in moderate-intensity (or higher) physical activity (time frame: Baseline (week 2) and WI Program (week 16)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.