NCT05764135

Brief Summary

Physical activity is important to maintain health, fitness, and function in people with spinal cord injury (SCI) and social support is one of the most effective ways to increase physical activity participation. However, a large proportion of people with SCI are physically inactive and do not engage in recreational activities due to environmental and physical challenges. Many people with SCI also experience challenges with social connection, which may make engaging in physical activities more difficult. The investigators are offering a new online application designed specifically for people with SCI. The purpose of the research is to develop and evaluate a new online app, called SCI-Lynx, that would allow people with SCI to connect with other people and support each other in their physical activity, exercise, or other health or personal goals over a one-month period. This research will also evaluate how SCI-Lynx affects self-efficacy and social support for exercise and provide new information on changing physical activity participation and social connection in people with SCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

February 28, 2023

Last Update Submit

November 7, 2025

Conditions

Keywords

Spinal Cord InjuryExercisePhysical ActivityDigital HealthSmartphone Application

Outcome Measures

Primary Outcomes (1)

  • Acceptability and Usability

    A standardized Usability Questionnaire that has been used in previous trials of other technologies by this team will be used. It consists of a series of questions that evaluate the participant's self-reported experiences with the SCI-Lynx on a number of characteristics, including ease of use and overall satisfaction. Each item is rated on a 7-point Likert scale. In addition, semi-structured interview questions will probe all participant's experiences with SCI-Lynx.

    Follow-up assessments (1 month after randomization)

Secondary Outcomes (5)

  • National Institutes of Health and Northwestern University Toolbox Item Bank version 2.0- Loneliness (Aged 18+)- Fixed Form

    Baseline and the follow-up assessments (1 month after randomization)

  • Spinal Cord Injury Exercise Self-Efficacy Scale

    Baseline and then follow-up assessments (1 month after randomization)

  • Physical Activity

    Baseline and then follow-up assessments (1 month after randomization)

  • Modified Sallis Social Support for Exercise Survey

    Baseline and then follow-up assessments (1 month after randomization)

  • Adherence

    Follow-up assessments (1 month after randomization)

Study Arms (2)

Intervention Group

EXPERIMENTAL

25 individuals will be randomized into the intervention group and download SCI-Lynx Mobile Application.

Behavioral: SCI-Lynx Mobile Application

Control Group

NO INTERVENTION

25 individuals will be randomized into the control group or usual care. They will then have an opportunity at the end of the 1-month to download the SCI-Lynx Mobile Application.

Interventions

. The SCI-Lynx application will enable people to find others with the same chronic condition who have similar exercise interests and goals. Individuals can make social connections, set, and track their exercise goals and support one another in their physical activities. It provides content customized for each condition to encourage participant's belief in the benefits of exercise and improve their self-efficacy for exercise through tracking of their own progress. An additional feature of SCI-Lynx is the ability to direct messages to other individuals or create subgroups within their network providing a further social support for individuals with SCI.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury (SCI) at least 1-year post-injury;
  • Use a wheelchair (including wheelchairs that are manual, electric or electric scooter) as their primary mobility mode;
  • Greater than 18 years of age; and
  • Able to provide informed consent.

You may not qualify if:

  • Not fluent in conversational English;
  • Any health condition that would suggest inability to complete requirements of this study; and
  • Does not have access to computer, tablet, or other device that does not have capability for Zoom video calls or downloading the SCI-Lynx mobile application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Study Officials

  • Thomas Storer, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There will be a total of 50 participants enrolled in the study, 25 will be randomized into the intervention group (SCI-Lynx App) and 25 into the control group (usual care).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

June 14, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations