BridgeMD
New treatment option for Spinal Cord Injuries
Official title Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
ClinicalTrials.gov ID: NCT05424172
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.