Recruiting

Smartphone Technology

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05424172

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stage-I, Group 1: Self monitoring using Non-interactive App

Stage-I, Group 2: Self monitoring using Interactive App

Stage-II, Groups 1a/2a: E-Coaching 1x per month

Stage-II, Groups 1b/2b: E-Coaching 2x per month

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05424172

Start date

Nov 2, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stage-I: Self Monitoring Exercise Using a Health App

Participants will be randomized into one of two groups: Group 1 (self monitoring using a non-interactive app), and Group 2 (self monitoring using an interactive app). Participants in both groups will be provided a customized exercise program to complete over the duration of the study. Within either app, participants will be able to view assigned exercises, log additional exercises completed, complete questionnaires as needed, and access additional resources. Participants will use their own smartphone to receive the health app. Participants will continue using their Stage-I app intervention for the entire duration of the study (weeks 1-24).

experimental: Stage-II: Strategy to Address Non-Adherence

After 12 weeks, the participants will be categorized as adherents or non-adherents based on their rates of adhering to the SCI exercise guidelines during Stage-I. Non-adherents (those who met the exercise guidelines <50% of the weeks) will be randomized to receive an augmented intervention of motivational interviewing-based e-coaching (2x per month or 4x per month) in addition to their Stage-I assigned app for 12 weeks (weeks 13-24) to further increase rates of exercise. All non-adherents who will be assigned to the e-coaching interventions will be asked to complete at least daily EMA surveys. A coach who is trained in motivational interviewing will review the EMA data and work collaboratively with participants to identify barriers and facilitators and develop individualized strategies to improve exercise adherence. Adherents (those who met the exercise guidelines >50% of the weeks) will continue with only their Stage-I assigned app intervention throughout Stage-II.

Interventions

Stage-I, Group 1: Self monitoring using Non-interactive App

Participants in Group 1 will have minimal features that affect compliance (notifications, rewards, EMA, etc.) and no modifications to their exercise program after initial prescription.

Stage-I, Group 2: Self monitoring using Interactive App

Participants in Group 2 will use the version of the exercise app that has been modified based on the findings from Phases 1 and 2 of this study. Group 2 will be able to use the full features of the interactive app including notifications, ability to submit videos, and non-synchronous messaging/communicating with the researcher. Additionally, participants in Group 2 will be asked to complete 2-5 EMA-based surveys daily to gain information about the participant's barriers and facilitators to exercise. The information from the EMA questionnaires will be used to progress and modify the exercise program at regular intervals for each participant in Group 2.

Stage-II, Groups 1a/2a: E-Coaching 1x per month

In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions two times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).

Stage-II, Groups 1b/2b: E-Coaching 2x per month

In addition to the Stage-I assigned app, participants will be asked to complete at least daily EMA questionnaires and e-coaching sessions four times a month throughout Stage-II (weeks 13-24). Participants will only receive the augmented e-coaching intervention if they were not adherent to the exercise guidelines for at least 50% of the weeks during Stage-I (weeks 1-12).

Primary outcome measure

  • Rate of Adherence to SCI exercise guidelines [ Time Frame: 12 weeks ]
  • Rate of Adherence to SCI exercise guidelines [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Sara Nataletti, PhD

(312)-238-7113snataletti@sralab.org

Arun Jayaraman, PT, PhD

(312)-238-6875ajayaraman@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sara Nataletti, PhD

312-238-7113snataletti@ricres.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Exercise
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-05-11.