Smartphone Feedback for Physical Activity in Spinal Cord Injury

Overseen By Shivayogi V Hiremath, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Temple University

Disqualifiers: Cardiovascular disease, Pressure injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

196 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Smartphone Feedback for Physical Activity in Spinal Cord Injury?

A pilot study showed that using a mobile health-based system to track physical activity and provide just-in-time adaptive interventions (JITAI) helped some individuals with spinal cord injury increase their energy expenditure and physical activity levels. This suggests that similar smartphone feedback treatments could be effective in promoting physical activity in this population. ^{1 2 3 4 5}

Is the Smartphone Feedback for Physical Activity intervention safe for people with spinal cord injury?

The research does not provide specific safety data for the Smartphone Feedback for Physical Activity intervention, but it involves tracking physical activity and providing feedback, which are generally considered safe activities. ^{1 3 4 5 6}

How is the Smartphone Feedback for Physical Activity treatment different from other treatments for spinal cord injury?

This treatment is unique because it uses a smartphone to provide real-time feedback and personalized messages to encourage physical activity, adapting to the user's behavior and needs. Unlike traditional methods, it leverages technology to offer a more interactive and responsive approach to managing physical activity levels in individuals with spinal cord injury. ^{1 3 4 7 8}

Research Team

Shivayogi V Hiremath, PhD

Principal Investigator

Temple University

Eligibility Criteria

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.

Inclusion Criteria

I mainly use a wheelchair to get around.

I am between 18 and 75 years old with a spinal cord injury.

I had a spinal cord injury at least 6 months ago.

Exclusion Criteria

I have been diagnosed with a traumatic brain injury.

I have health issues like heart disease or infections that limit my activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Baseline assessments including non-traumatic SCI, age, sex, race/ethnicity, SCI level of injury, and functional level

2 weeks

2 visits (in-person)

WI Program

Participants engage in the web-based physical activity intervention program

14 weeks

3 visits (virtual)

WI + JITAI Program

Participants receive just-in-time adaptive interventions alongside the WI program

14 weeks

Micro-randomized feedback sessions (virtual)

Physical Activity Sustainability

Participants continue to have access to the WI program information and JITAI feedback

8 weeks

Ongoing virtual access

Follow-up

Participants are monitored for sustained physical activity levels and other health outcomes

4 weeks

2 visits (virtual)

Treatment Details

Interventions

• JITAI Goal Setting
• JITAI physical activity message
• WI program
• WI Program Reminder

Trial Overview 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.

Participant Groups

Group I: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Experimental Treatment 9 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) program Active Control 3 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).

JITAI physical activity message is already approved in United States for the following indications:

Approved in United States as JITAI Physical Activity Message for:

• Increasing physical activity levels in individuals with spinal cord injury

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Good Shepherd Rehabilitation Network

Collaborator

Trials

2

Recruited

260+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Albert Einstein Healthcare Network

Collaborator

Trials

65

Recruited

869,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Magee Rehabilitation Hospital, Jefferson Health

Collaborator

Trials

2

Recruited

220+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Findings from Research

A study involving 19 manual wheelchair users with chronic spinal cord injury found that accelerometers and self-reported assessments of physical activity showed low agreement, indicating that they measure different aspects of physical activity.

While accelerometers were effective in detecting brief or intermittent activities, the self-report measure was better for capturing activities like resistance training and wheeling on inclines, suggesting that using both methods together may provide a more comprehensive view of physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury). Ma, JK., McCracken, LA., Voss, C., et al.[2021]

A study involving 13 individuals with spinal cord injury (SCI) and 9 healthcare professionals identified key features for a web-based self-management physical activity portal, emphasizing the importance of knowledge, self-regulation strategies, and interactivity to motivate physical activity engagement.

Participants rated the likelihood of using and promoting the portal highly, indicating strong interest in a tailored online platform that could help individuals with SCI manage their condition and increase physical activity adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Physical Activity Portal for Individuals Living With a Spinal Cord Injury: Qualitative Study. Pancer, M., Manganaro, M., Pace, I., et al.[2020]

Individuals with spinal cord injury (SCI) prefer passive sources like the Internet and DVDs for receiving physical activity information, highlighting the importance of accessible media.

Peers and health service providers are seen as the most trusted messengers for delivering physical activity messages, indicating a need for collaboration among healthcare professionals to tailor information for different stages of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. Letts, L., Martin Ginis, KA., Faulkner, G., et al.[2022]

A mobile health-based system was used to track physical activity (PA) levels in 20 individuals with spinal cord injury (SCI) over three phases, showing that 69% of participants increased their light- and moderate-intensity PA when provided with just-in-time adaptive interventions (JITAI).

This pilot study suggests that using a sensor-enabled mobile JITAI can effectively promote higher PA levels in individuals with SCI, indicating a promising direction for future research to further evaluate its efficacy in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health-based physical activity intervention for individuals with spinal cord injury in the community: A pilot study. Hiremath, SV., Amiri, AM., Thapa-Chhetry, B., et al.[2020]

The Accessercise smartphone app was developed to improve physical activity in individuals with spinal cord injuries (SCI) by targeting 13 specific behaviors, such as goal setting and increasing self-confidence, which are crucial for reducing sedentary lifestyles.

Using the Behaviour Change Wheel (BCW) framework, the study identified key mechanisms that could enhance the app's effectiveness, suggesting that it could serve as a model for future interventions aimed at improving health outcomes for people with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the behaviour change wheel to assess the theoretical underpinning of a novel smartphone application to increase physical activity in adults with spinal cord injuries. Haley, JA., Rhind, DJA., Maidment, DW.[2023]

The Apple Watch Series 4 shows a significant improvement in measuring wheelchair pushes for users with spinal cord injury, with a mean absolute percent error (MAPE) of 9.20%, indicating it can effectively track physical activity in this population.

In comparison to the older Series 1, the Series 4 provides more accurate data, making it a promising tool for objectively measuring physical activity in wheelchair users, although it tends to overestimate the number of pushes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. Benning, NH., Knaup, P., Rupp, R.[2022]

The Physical Activity Instrument-SCI (PAI-SCI) demonstrated a moderate correlation with accelerometer data, indicating it can reliably assess physical activity levels in individuals with spinal cord injuries, with a correlation coefficient of r = 0.42.

The PAI-SCI effectively differentiated physical activity levels between individuals with upper and lower level spinal cord injuries, but its reliability varied across different activity subscales, suggesting further research is needed before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Inventory for Patients with Spinal Cord Injury. Butler, JA., Miller, T., O'Connell, S., et al.[2021]

A study involving 11 adults with incomplete spinal cord injury found that a minimum of 2 days of step activity monitoring is needed to reliably measure walking activity, achieving a reliability coefficient of 0.80.

The average daily step count for participants was 1,281 steps, indicating that even short monitoring periods can provide stable measures for evaluating the effectiveness of activity-based rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of daily step activity monitoring in adults with incomplete spinal cord injury. Ishikawa, S., Stevens, SL., Kang, M., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury). [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Physical Activity Portal for Individuals Living With a Spinal Cord Injury: Qualitative Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mobile health-based physical activity intervention for individuals with spinal cord injury in the community: A pilot study. [2020]

5. China pubmed.ncbi.nlm.nih.gov

Applying the behaviour change wheel to assess the theoretical underpinning of a novel smartphone application to increase physical activity in adults with spinal cord injuries. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Inventory for Patients with Spinal Cord Injury. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Reliability of daily step activity monitoring in adults with incomplete spinal cord injury. [2019]