NCT05424172 Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
| NCT ID | NCT05424172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-11-02 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation.
Eligibility Criteria
Inclusion Criteria: Phase 1 * Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI * 18-80 years of age * English-speaking * Willing to download the study apps Exclusion Criteria: Phase 1 * Severe visual or cognitive problems that would affect the ability to complete the study * Does not own, or is unable to use a smartphone Inclusion Criteria: Phase 2 and 3 * Individual with diagnosis of SCI, complete (only paraplegia) or incomplete, cervical C3- C4 and below * 18-80 years of age * English-speaking * Use a wheelchair as primary means of mobility or walk with or without assistive equipment * At least 1-year post-SCI * Not adhering to SCI-specific exercise guidelines as ascertained by self-report or during structured phone interview * Interested in increasing exercise levels * Ownership of a smartphone that can be used for the study and has a data plan * Willing to successfully download and learn to use the study apps * Able and willing to give written consent and comply with study procedures, including multiple in person follow-up visits Exclusion Criteria: Phase 2 and 3 * Trauma or surgery in the past three months * An active stage 3 or 4 pressure ulcer * Medically unstable to perform the home-based exercise as determined by Dr. Chen and his team, the evaluating physical therapist, or the participants' primary care physician. * Unable to use at least one set of extremities to exercise * Enrolled in a structured exercise program over the past three months * Severe visual or cognitive problems that would affect the ability to complete the study * Does not own, or is unable to use a smartphone
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05424172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05424172 currently recruiting?
Yes, NCT05424172 is actively recruiting participants. Contact the research team at snataletti@sralab.org for enrollment information.
Where is the NCT05424172 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05424172 clinical trial?
NCT05424172 is sponsored by Shirley Ryan AbilityLab. The trial plans to enroll 50 participants.