Chronic Brain InjurySPIRITClubCBINCT07169370
SPIRIT Club Chronic Brain Injury Exercise Platform
A study testing SPIRIT Club CBI Pathway in people with Chronic Brain Injury, run by Ohio State University at 1 site in United States.
Trial summary
Many physical fitness centers and online exercise programs are not designed to support people with intellectual and developmental disabilities. To address this, the investigators are collaborating with SPIRIT Club, a company specializing in fitness for people with disabilities, to improve their platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Brain Injury
- What is being tested?
- SPIRIT Club CBI Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older with chronic brain injury (CBI)
- At least 9 months post-injury
- Is able to able to be able to demonstrate the ability to meet at least one of the following functional mobility scenarios: 1) able to walk with or without an assistive device or with no more than contact guard assist from a caregiver for steadiness checks and proprioceptive support, 2) able to stand up from a chair with no assistance or no more than contact guard assist from a caregiver for steadiness and proprioceptive support, and/or 3) able to maintain steady seated balance in a chair or wheelchair and able to lift at least one limb with minimal assist (<25%) from a caregiver against gravity
- Currently exercising less than 60 minutes per week
- Able to follow simple commands
- Participant is his/her own legal authorized representative (LAR) or LAR is able to verify they can follow simple commands and participate in study and support consenting and participation processes
- Provides confirmation of medical clearance from physician to participate in moderate levels of activity without supervision from a licensed healthcare provider
Who cannot join
- Unsafe independent functional mobility observed during the functional mobility screen and no available caregiver/carepartner to facilitate participation in the study and provide assistance while using the SPIRIT Club platform
- Being advised by any healthcare provider to avoid or restrict participation in moderate to high-intensity physical activity
- Uncontrolled blood pressure, unstable angina, severe joint disease, uncontrolled or untreated dizziness or vertigo, or other medical issue precluding exercises leading to lack of clearance from a physician
- - e.g.,
- Unable to follow simple commands or persistent post-traumatic amnesia
- Presence of expressive aphasia
Show all 10Show fewer
- Lack of fluency in English
- Unable to follow simple commands or persistent post-traumatic amnesia
- Regular participation (2 or more days per week) in a structured fitness program or platform (e.g., group exercise classes or personal training)
- Regular participation (average of 1 or more days per week) in physical therapy services specifically for brain injury rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Catherine Quatman-Yates, PT, DPT, PhD, 814-440-2598, catherine.quatman-yates@osumc.edu
Annie Truelove, MPH, Anna.Truelove@osumc.edu
About this study
Official title: SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
Many physical fitness centers and online exercise programs are not designed to support people with intellectual and developmental disabilities. To address this, the investigators are collaborating with SPIRIT Club, a company specializing in fitness for people with disabilities, to improve their platform. The goal is to create a new section of the platform specifically for people with chronic brain injury (CBI). The investigators will test and refine this new section to see how well it works for people with CBI in real-life situations. The research will focus on conducting a study with 60 people who have CBI to see if the new section helps them be more active and confident in their ability to exercise. Half will use the new section, and the other half will just be monitored for their activity. The investigators includes experts in fitness and rehabilitation for people with disabilities from industry, clinical settings, and research.
- Conditions
- Chronic Brain Injury
- Being tested
- SPIRIT Club CBI Pathway
- Keywords
- fitness platform, chronic brain injury
- Medical subject headings
- Brain Injury, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIRIT Club CBI PathwayBehavioural
Also called CBI Pathway, SPIRIT Club streaming fitness platform
A tailored, on-demand exercise and education program delivered via the SPIRIT Club virtual streaming platform. Content includes progressive adaptive workouts, safety videos, screening checkpoints, and prompts for a support person. Participants choose classes designed specifically for adults ≥9 months post-brain injury and after being placed in the appropriate archetype, complete activity surveys, and earn incentives for adherence. They are instructed on current physical activity guidelines (≥150 min moderate or ≥75 min vigorous activity per week) and to follow the CBI Pathway at their comfort level. Content was co-developed with clinical experts and survivors to ensure both usability and safety.
| Study group | Role | What they receive |
|---|---|---|
| SPIRIT Club CBI Pathway | Experimental | Participants receive free, two-month access to the SPIRIT Club CBI Pathway on-demand streaming platform, featuring targeted educational modules and adaptive exercise programming designed specifically for CBI survivors and their caregivers, plus a Fitbit Inspire 3 to wear continuously for the purposes of activity monitoring over the intervention period. Receives: Behavioral: SPIRIT Club CBI Pathway |
| Activity Monitoring Only | No intervention | There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Feasibility will be assessed over the intervention period using recruitment rate (number of enrolled participants relative to those approached) as an objective indicator.
Measured: From enrollment through completion of the intervention (Week 8).
Attendance of SPIRIT Club CBI Pathway Sessions
Feasibility will be assessed over the intervention period using attendance (number of sessions completed) as an objective indicator.
Measured: From enrollment through completion of the intervention (Week 8).
Attrition Rate
Feasibility will be assessed over the intervention period using attrition rate (proportion withdrawing before end of the intervention period as an objective indicator.
Measured: From enrollment through completion of the intervention (Week 8).
Unplanned Study-team contacts during enrollment
Feasibility will be assessed over the intervention period using unplanned study-team contacts (number of emails and/or calls outside scheduled check-ins; total and per participant) as an objective indicator.
Measured: From enrollment through completion of the intervention (Week 8).
Accessibility Issues
Feasibility will be assessed over the intervention period using accessibility issues (number of instances where participants could not successfully acquire or use the streaming platform or data-collection tools; participant and/or staff team reported) as an objective indicator.
Measured: From enrollment through completion of the intervention (Week 8).
Safety of the SPIRIT Club CBI Pathway Platform
Safety will be assessed through the documentation of exercise-related adverse events (number per participant and total over the intervention period).
Measured: From enrollment through completion of the intervention (Week 8).
Acceptability Survey
Acceptability will be evaluated immediately after the 8-week program or at the time of withdrawal using an electronically administered survey. The investigators will assess acceptability based on answers to a 5-point satisfaction scale (1 = very dissatisfied to 5 = very satisfied) for (1) overall program content and (2) usability and a series of binary yes/no responses to the following questions: "Was the program worth the participant's time?" and "Would the participant recommend it to others with CBI?"; and open-ended comments capturing likes, dislikes, and improvement suggestions.
Measured: At program end (Week 8).
Exercise Self-Efficacy Scale Score
Electronic survey administered to participant. Change in total score on the validated 6-item exercise self-efficacy scale, from baseline to Week 8, which assesses participants' confidence to engage in physical activity despite common barriers.
Measured: Baseline and Week 8
Secondary outcomes (6)
Step Count
Activity is monitored using a Fitbit Inspire 3 wearable device, which captures daily step count.
Measured: From enrollment through completion of the intervention (Week 8).
Active Minutes
This outcome provides a comprehensive assessment of participants' physical activity patterns by a Fitbit Inspire 3 wearable device, which captures active minutes in intensity zones.
Measured: From enrollment through completion of the intervention (Week 8).
Platform Utilization - Total Classes Initiated
Utilization metrics will be drawn from the SPIRIT Club streaming platform's automatic logs on a weekly basis (Weeks 1-8), including total number of classes initiated These data quantify how frequently and intensively participants engage with the CBI Pathway.
Measured: Weekly summaries during Weeks 1-8.
Platform Utilization - Minutes of Video Streamed
Utilization metrics will be drawn from the SPIRIT Club streaming platform's automatic logs on a weekly basis (Weeks 1-8), including cumulative minutes of video streamed (group total and per participant).
Measured: Weekly summaries during Weeks 1-8.
Daily Activity Log - Tracked Activity Counts
The total number of activities completed each day, as measured by a participant-completed daily activity log.
Measured: From enrollment through completion of the intervention (Week 8)
Daily Activity Log - Tracked Activity Minutes
The total duration of activity in minutes each day, as measured by a participant-completed daily activity log.
Measured: From enrollment through completion of the intervention (Week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-assignment, single-masked interventional study with two arms: Intervention Arm: Participants receive access to the SPIRIT Club CBI Pathway streaming platform and a Fitbit for continuous activity monitoring. Control Arm: Participants receive a Fitbit alone, plus weekly check-ins, but no platform access. Participants are randomized 1:1 and followed for 8 weeks. Outcome assessors remain masked to arm assignment. Primary feasibility and activity outcomes (e.g., tracked activity, exercise self-efficacy) are measured at baseline and week 8.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Catherine Quatman-Yates, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169370
- Sponsor's protocol ID
- 2024H0167
- Other IDs
- R44HD112248
- Acronym
- SPIRITClubCBI
- Status last verified
- Mar 2026
- First submitted
- 28 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy and confidentiality of our study participants, individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT Club CBI Pathway: A Novel Streaming Platform for Physical Activity and Wellness Promotion for Chronic Brain Injury Survivors
- ClinicalTrials.gov ID
- NCT07169370
- Acronym / sponsor ID
- SPIRITClubCBI / 2024H0167
- Conditions
- Chronic Brain Injury
- Keywords
- fitness platform, chronic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many physical fitness centers and online exercise programs are not designed to support people with intellectual and developmental disabilities. To address this, the investigators are collaborating with SPIRIT Club, a company specializing in fitness for people with disabilities, to improve their platform. The goal is to create a new section of the platform specifically for people with chronic brain injury (CBI). The investigators will test and refine this new section to see how well it works for people with CBI in real-life situations. The research will focus on conducting a study with 60 people who have CBI to see if the new section helps them be more active and confident in their ability to exercise. Half will use the new section, and the other half will just be monitored for their activity. The investigators includes experts in fitness and rehabilitation for people with disabilities from industry, clinical settings, and research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-assignment, single-masked interventional study with two arms: Intervention Arm: Participants receive access to the SPIRIT Club CBI Pathway streaming platform and a Fitbit for continuous activity monitoring. Control Arm: Participants receive a Fitbit alone, plus weekly check-ins, but no platform access. Participants are randomized 1:1 and followed for 8 weeks. Outcome assessors remain masked to arm assignment. Primary feasibility and activity outcomes (e.g., tracked activity, exercise self-efficacy) are measured at baseline and week 8.
| Arm | Type | Receives |
|---|---|---|
| SPIRIT Club CBI Pathway | Experimental | Behavioral: SPIRIT Club CBI PathwayParticipants receive free, two-month access to the SPIRIT Club CBI Pathway on-demand streaming platform, featuring targeted educational modules and adaptive exercise programming designed specifically for CBI survivors and their caregivers, plus a Fitbit Inspire 3 to wear continuously for the purposes of activity monitoring over the intervention period. |
| Activity Monitoring Only | No intervention | –There is no intervention in this Arm. In order to track activity, participants will undergo the same activity monitoring procedures as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older with chronic brain injury (CBI)
- At least 9 months post-injury
- Is able to able to be able to demonstrate the ability to meet at least one of the following functional mobility scenarios: 1) able to walk with or without an assistive device or with no more than contact guard assist from a caregiver for steadiness checks and proprioceptive support, 2) able to stand up from a chair with no assistance or no more than contact guard assist from a caregiver for steadiness and proprioceptive support, and/or 3) able to maintain steady seated balance in a chair or wheelchair and able to lift at least one limb with minimal assist (<25%) from a caregiver against gravity
- Currently exercising less than 60 minutes per week
- Able to follow simple commands
Key exclusion criteria (10 listed)
- Unsafe independent functional mobility observed during the functional mobility screen and no available caregiver/carepartner to facilitate participation in the study and provide assistance while using the SPIRIT Club platform
- Being advised by any healthcare provider to avoid or restrict participation in moderate to high-intensity physical activity
- Uncontrolled blood pressure, unstable angina, severe joint disease, uncontrolled or untreated dizziness or vertigo, or other medical issue precluding exercises leading to lack of clearance from a physician
- - e.g.,
- Unable to follow simple commands or persistent post-traumatic amnesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIRIT Club CBI PathwayAlso: CBI Pathway, SPIRIT Club streaming fitness platformA tailored, on-demand exercise and education program delivered via the SPIRIT Club virtual streaming platform. Content includes progressive adaptive workouts, safety videos, screening checkpoints, and prompts for a support person. Participants choose classes designed specifically for adults ≥9 months post-brain injury and after being placed in the appropriate archetype, complete activity surveys, and earn incentives for adherence. They are instructed on current physical activity guidelines (≥150 min moderate or ≥75 min vigorous activity per week) and to follow the CBI Pathway at their comfort level. Content was co-developed with clinical experts and survivors to ensure both usability and safety. | Behavioural | SPIRIT Club CBI Pathway |
Primary outcome
Recruitment Rate
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using recruitment rate (number of enrolled participants relative to those approached) as an objective indicator.
Attendance of SPIRIT Club CBI Pathway Sessions
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attendance (number of sessions completed) as an objective indicator.
Attrition Rate
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using attrition rate (proportion withdrawing before end of the intervention period as an objective indicator.
Unplanned Study-team contacts during enrollment
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using unplanned study-team contacts (number of emails and/or calls outside scheduled check-ins; total and per participant) as an objective indicator.
Accessibility Issues
Time frame: From enrollment through completion of the intervention (Week 8).
Feasibility will be assessed over the intervention period using accessibility issues (number of instances where participants could not successfully acquire or use the streaming platform or data-collection tools; participant and/or staff team reported) as an objective indicator.
Safety of the SPIRIT Club CBI Pathway Platform
Time frame: From enrollment through completion of the intervention (Week 8).
Safety will be assessed through the documentation of exercise-related adverse events (number per participant and total over the intervention period).
Acceptability Survey
Time frame: At program end (Week 8).
Acceptability will be evaluated immediately after the 8-week program or at the time of withdrawal using an electronically administered survey. The investigators will assess acceptability based on answers to a 5-point satisfaction scale (1 = very dissatisfied to 5 = very satisfied) for (1) overall program content and (2) usability and a series of binary yes/no responses to the following questions: "Was the program worth the participant's time?" and "Would the participant recommend it to others with CBI?"; and open-ended comments capturing likes, dislikes, and improvement suggestions.
Exercise Self-Efficacy Scale Score
Time frame: Baseline and Week 8
Electronic survey administered to participant. Change in total score on the validated 6-item exercise self-efficacy scale, from baseline to Week 8, which assesses participants' confidence to engage in physical activity despite common barriers.
6 secondary outcomes
Step Count
Time frame: From enrollment through completion of the intervention (Week 8).
Active Minutes
Time frame: From enrollment through completion of the intervention (Week 8).
Platform Utilization - Total Classes Initiated
Time frame: Weekly summaries during Weeks 1-8.
Platform Utilization - Minutes of Video Streamed
Time frame: Weekly summaries during Weeks 1-8.
Daily Activity Log - Tracked Activity Counts
Time frame: From enrollment through completion of the intervention (Week 8)
Daily Activity Log - Tracked Activity Minutes
Time frame: From enrollment through completion of the intervention (Week 8).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Official homepage for SPIRIT Club, a virtual on-demand fitness streaming platform offering adaptive, progressive exercise classes and educational modules for people with disabilities, including those with chronic brain injury.Link provided by the sponsor.
- Individual participant dataSharing planned: No. To protect the privacy and confidentiality of our study participants, individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ohio State University Wexner Medical Center
Columbus, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIRIT Club CBI Pathway in people with Chronic Brain Injury, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From enrollment through completion of the intervention (Week 8).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.