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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773692
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Northeastern University
Magee Rehabilitation Hospital, Jefferson Health
MossRehab: Einstein Healthcare Network
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Passive feedback and JITAI Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: Participants were aware of the phase of the study they were in.
Primary Purpose: Prevention
Official Title: Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)

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.





Primary Outcome Measures :
  1. Change in Physical Activity level [ Time Frame: 3 months ]
    Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.

  2. Change in Light-Intensity Physical Activity [ Time Frame: 3 months ]
    Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.

  3. Change in Moderate and Vigorous-Intensity Physical Activity [ Time Frame: 3 months ]
    Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.


Secondary Outcome Measures :
  1. Change in Light-intensity Leisure Time Physical Activity [ Time Frame: 3 months ]
    Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.

  2. Change in Moderate and Vigorous-intensity Leisure Time Physical Activity [ Time Frame: 3 months ]
    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. Change in Pain level for wheelchair users [ Time Frame: 3 months ]
    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.

  4. Change in Pain level [ Time Frame: 3 months ]
    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.

  5. Change in Disability score due to Pain [ Time Frame: 3 months ]
    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.

  6. Change in Fatigue [ Time Frame: 3 months ]
    The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773692


Locations
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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
The Craig H. Neilsen Foundation
Northeastern University
Magee Rehabilitation Hospital, Jefferson Health
MossRehab: Einstein Healthcare Network
Investigators
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Principal Investigator: Shivayogi V Hiremath, PhD Temple University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03773692    
Other Study ID Numbers: 23822
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets generated during the current study are not publicly available as the authors do not have the permission to share participants' data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
Spinal Cord Injuries
Physical Activity
Mobile-health
Just-in-time-adaptive intervention
Real-time feedback
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System