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Smartphone Feedback for Physical Activity in Spinal Cord Injury
Phase 2
Recruiting
Led By Shivayogi V Hiremath, PhD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Awards & highlights
Study Summary
This trial is studying an intervention that uses a sensor to detect physical activity and then gives feedback to help people with spinal cord injuries be more active.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-drug interventions like information messages and goal setting via smartphone, there are no direct side effects as seen with medications; however, participants may experience fatigue or discomfort from increased physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (weeks 0 and 2), wi program (weeks 2, 8 and 16), physical activity sustainability (week 24)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in moderate-intensity (or higher) physical activity
Change in proximal physical activity
Self-reported change in moderate-intensity (or higher) leisure time physical activity
+1 moreSecondary outcome measures
Fatigue level
Pain level number
Pain level type
Other outcome measures
Age
American Spinal Injury Association Impairment Scale (AIS)
Assistive or Mobility device use
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)Experimental Treatment9 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) programActive Control3 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).
Find a Location
Who is running the clinical trial?
University of MichiganOTHER
1,798 Previous Clinical Trials
6,377,942 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,601 Total Patients Enrolled
Northeastern UniversityOTHER
88 Previous Clinical Trials
61,114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal cord injury is at or below the C5 level.It has been over 6 months since my spinal cord injury.I mainly use a wheelchair to get around.I have been diagnosed with a traumatic brain injury.I have health issues like heart disease or infections that limit my activities.I am between 18 and 75 years old with a spinal cord injury.I had a spinal cord injury at least 6 months ago.My spinal cord injury is at or below the C5 level.I can use my arms to exercise.I am between 18 and 75 years old.I can use my arms to exercise.You need to fill out a questionnaire to make sure you are ready for physical activity.I use a wheelchair as my main way to get around most of the time.
Research Study Groups:
This trial has the following groups:- Group 1: Web-based physical activity intervention (WI) program
- Group 2: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I potentially be accepted into this examination?
"This experiment seeks 196 volunteers aged 18 to 75 who have been diagnosed with either traumatic or non-traumatic SCI. Furthermore, these participants must meet the following prerequisites: anatomical impairment of C5 and below; at least six months elapsed post-SCI diagnosis; primary mobility is a wheelchair (at least 80% usage); readiness for physical activity as determined by Physical Activity Readiness Questionnaire; familiarity with smartphone and smartwatch technology."
Answered by AI
Is enrollment still open for this investigation?
"According to clinicaltrials.gov, this trial is now closed for enrollment; the initial posting was on July 25th 2022 and it was last updated June 24th of that year. Fortunately, there are 900 other investigations open at present which may be accepting applicants."
Answered by AI
Has the WI program received authorization from the FDA?
"WI program has been assigned a score of 2, owing to the existing clinical data that demonstrate some degree of safety though there is yet no proof of efficacy."
Answered by AI
Is the participant demographic for this trial limited to persons aged 35 and under?
"This research study is seeking participants aged 18 or older and under 75 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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