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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773692
• Other study ID #: 23822
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: November 21, 2018

Study information

• Verified date: December 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Lack of regular physical activity (PA) in the general population is a top public health concern, and this problem is even more acute among individuals with spinal cord injury (SCI). Research has shown that only a small percentage (<20%) of persons with SCI reported consistent PA. Individuals with SCI also experience secondary conditions such as pain, fatigue, weight gain, and deconditioning, conditions that are considered preventable through PA and exercise interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• have active pelvic or thigh wounds (pressure ulcers)

• have a history of cardiovascular disease

• are pregnant (self-report).

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Temple University	Magee Rehabilitation Hospital, Jefferson Health, MossRehab: Einstein Healthcare Network, Northeastern University, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity level	Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.	3 months
Primary	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
Primary	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	Change in Light-intensity Leisure Time Physical Activity	Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.	3 months
Secondary	Change in Moderate and Vigorous-intensity Leisure Time Physical Activity	Minutes of moderate and vigorous-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.	3 months
Secondary	Change in Pain level for wheelchair users	The pain level for wheelchair users is collected using the Wheelchair Users Shoulder Pain Index. The score ranges from a minimum pain level of 0 to a maximum pain level of 150.	3 months
Secondary	Change in Pain level	The general pain level was collected using the Chronic Pain Grade scale. The pain intensity score ranges from a minimum pain level of 0 to a maximum pain level of 100.	3 months
Secondary	Change in Disability score due to Pain	The general pain level was collected using the Chronic Pain Grade scale. Disability scores range from a minimum of 0 to a maximum of 100.	3 months
Secondary	Change in Fatigue	The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.	3 months