Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury

NCT03773692 | Completed

• 1 other identifier: 23822
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to develop algorithms that incorporate each individual's automatically detected physical activity (PA) level and a clinician's PA level recommendation to provide a smartphone application that helps a person set safe and highly personalized PA goals. By adapting the goals in real-time based on the person's actual behavior, the system aims to keep the individual feeling positive and motivated towards a change in the PA behavior.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; Physical Activity; Mobile-health; Just-in-time-adaptive intervention; Real-time feedback

Outcome Measures

Primary Outcomes (3)

• Change in Physical Activity level

  Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.

  3 months

• Change in Light-Intensity Physical Activity

  Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.

  3 months

• Change in Moderate and Vigorous-Intensity Physical Activity

  Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.

  3 months

Secondary Outcomes (6)

• Change in Light-intensity Leisure Time Physical Activity

  3 months

• Change in Moderate and Vigorous-intensity Leisure Time Physical Activity

  3 months

• Change in Pain level for wheelchair users

  3 months

• Change in Pain level

  3 months

• Change in Disability score due to Pain

  3 months

Study Arms (1)

Passive feedback and JITAI

EXPERIMENTAL

Passive feedback and JITAI Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)

Behavioral: Passive feedback and JITAI

Interventions

Passive feedback and JITAI BEHAVIORAL

Second Phase - PA Level Feedback A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information. Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI) The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA.

Passive feedback and JITAI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18-65 years of age
• have been diagnosed with spinal cord injury
• are at least 6 months post injury
• use a manual wheelchair as their primary means of mobility (\>80% of the time)
• self-propel their wheelchair
• are medically stable
• have experience using a smartphone.

You may not qualify if:

• have active pelvic or thigh wounds (pressure ulcers)
• have a history of cardiovascular disease
• are pregnant (self-report).

Sponsors & Collaborators

• Temple University: lead
• The Craig H. Neilsen Foundation: collaborator
• Northeastern University: collaborator
• Magee Rehabilitation Hospital, Jefferson Health: collaborator
• MossRehab: Einstein Healthcare Network: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (6)

• Rimmer JH, Schiller W, Chen MD. Effects of disability-associated low energy expenditure deconditioning syndrome. Exerc Sport Sci Rev. 2012 Jan;40(1):22-9. doi: 10.1097/JES.0b013e31823b8b82.

  PMID: 22016146 BACKGROUND

• Williams TL, Smith B, Papathomas A. The barriers, benefits and facilitators of leisure time physical activity among people with spinal cord injury: a meta-synthesis of qualitative findings. Health Psychol Rev. 2014;8(4):404-25. doi: 10.1080/17437199.2014.898406. Epub 2014 Mar 26.

  PMID: 25211208 BACKGROUND

• Tawashy AE, Eng JJ, Lin KH, Tang PF, Hung C. Physical activity is related to lower levels of pain, fatigue and depression in individuals with spinal-cord injury: a correlational study. Spinal Cord. 2009 Apr;47(4):301-6. doi: 10.1038/sc.2008.120. Epub 2008 Oct 21.

  PMID: 18936771 BACKGROUND

• Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Estimation of Energy Expenditure for Wheelchair Users Using a Physical Activity Monitoring System. Arch Phys Med Rehabil. 2016 Jul;97(7):1146-1153.e1. doi: 10.1016/j.apmr.2016.02.016. Epub 2016 Mar 11.

  PMID: 26976800 BACKGROUND

• Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Detection of physical activities using a physical activity monitor system for wheelchair users. Med Eng Phys. 2015 Jan;37(1):68-76. doi: 10.1016/j.medengphy.2014.10.009. Epub 2014 Nov 10.

  PMID: 25465284 BACKGROUND

• Canori A, Amiri AM, Thapa-Chhetry B, Finley MA, Schmidt-Read M, Lamboy MR, Intille SS, Hiremath SV. Relationship between pain, fatigue, and physical activity levels during a technology-based physical activity intervention. J Spinal Cord Med. 2021 Jul;44(4):549-556. doi: 10.1080/10790268.2020.1766889. Epub 2020 Jun 4.

  PMID: 32496966 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Shivayogi V Hiremath, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants were aware of the phase of the study they were in.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each individual will take part in the study for three phases, each with a duration of one month. The first month will involve collecting baseline PA levels. The second and third months of the study will provide the participants with passive PA level feedback and just-in-time persuasive feedback about their PA levels, respectively.

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 12, 2018
• Study Start: July 31, 2017
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)