Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury
NCT ID: NCT03773692
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-07-31
2018-11-21
Brief Summary
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Detailed Description
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The objective of this proposed study is to develop algorithms that incorporate each individual's PA level and a clinician's PA level recommendation to provide a mobile phone application that helps a person set PA goals that are safe, but also highly personalized. 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.
Aim 1: Extend and utilize Physical Activity Monitor System (PAMS) to track PA levels, sedentary behavior, and secondary conditions such as pain, fatigue, and deconditioning in community settings.
Aim 2: Extend and utilize PAMS to passively monitor PA and provide continuous, but passive feedback about PA levels to individuals with SCI in community settings.
Aim 3: Extend and utilize PAMS to passively monitor PA and provide just-in-time persuasive and adaptive feedback to motivate individuals with SCI in community settings.
Sample size: A total of 20 individuals with SCI will take part in the study. The sample size for this pilot study is based on budget constraints and other pilot studies. This study will provide the pilot data required to compute the power for future studies.
Statistical Analysis: Univariate analysis will be performed to obtain a range of values and the central tendency for variables such as PA levels and sedentary behaviors. Sedentary behavior will be assessed by the time duration of non-movement of individuals with SCI and not just the total duration of being seated in their wheelchairs.
The investigators hypothesize that the PA level of individuals with SCI in community will be low compared to the PA level recommendations for individuals with disabilities in general. Furthermore, the sedentary behavior of individuals with SCI will be high compared to the general population.
Multiple regression analysis will be performed to assess a relationship between secondary conditions such as pain (scores), fatigue (scores), and deconditioning (reduced capacity scores) and PA levels. The investigators postulate that secondary conditions will be negatively correlated with the PA levels.
Repeated measures general linear model (GLM) analysis will be performed to assess the change in PA levels, sedentary behaviors and secondary conditions. In addition, linear mixed model analysis will be performed to develop a personal intercept (and maybe slope) for each participant compared to the mean intercept for each group. Mixed effects model analysis will provide correct estimates of intervention (passive feedback and just-in-time adaptive feedback) and other fixed effects (within-subjects factor) in the presence of correlated data (each participant at different time points) that arise from a data hierarchy (group). Non-parametric tests will be performed if the assumptions for parametric tests are not met.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Passive feedback and JITAI
Passive feedback and JITAI
Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)
Passive feedback and JITAI
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.
Interventions
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Passive feedback and JITAI
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* have a history of cardiovascular disease
* are pregnant (self-report).
18 Years
65 Years
ALL
No
Sponsors
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The Craig H. Neilsen Foundation
OTHER
Northeastern University
OTHER
Magee Rehabilitation Hospital, Jefferson Health
UNKNOWN
MossRehab: Einstein Healthcare Network
UNKNOWN
Temple University
OTHER
Responsible Party
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Principal Investigators
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Shivayogi V Hiremath, PhD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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23822
Identifier Type: -
Identifier Source: org_study_id