Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- MetroHealth Medical Center
- Study ID
- NCT06734026
- Status
- Recruiting
Conditions
- Traumatic Brain Injury (TBI) Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cafe Therapy — BEHAVIORALParticipants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher. Participants will complete at least 18 sessions of training within the time frame. Participants will run the Café with supervision from a researcher, serving customers prepackaged food and drinks per our protocol, along with guidance and direction from a therapist, once a week. Participants will be responsible for interacting with customers and arranging supplies. On a weekly basis, participants will be asked how they feel (for example tired, stressed, overwhelmed, etc) before and after their session and to rate how well they performed in the café.
Study Details
The goal of this study is to learn if a enhanced environment (Metro Café) with multi model approach (an approach that combines several therapies) in chronic traumatic brain injury improves outcomes of recovery better than traditional therapy. The main questions it aims to answer are: * Determine the amount of therapy dosage (speech, cognition, arm and leg movements) obtained during the Metro Café therapy session. * Evaluate the connection between environmental enrichment dosage (the Metro Café) and clinical outcome scores. Researchers will compare Metro Café Treatment to those who do not receive this treatment to see if better improvements in function after a traumatic brain injury are seen in the Metro Café Treatment Participants will train in the Metro Cafe during the 2-month gap between assessments, for a total of 18 training sessions, each up to 2 hours, 3 times per week. Participants will greet and serve customers drinks and snacks, maintain food supplies at the counters and performs housekeeping tasks with advice and assistance from a supervising researcher as needed,
Key Dates
- Start date
- Apr 8, 2025
- Status verified
- Feb 2026
- Primary completion
- Jan 15, 2028
- Completion
- Jan 15, 2029
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cafe TherapyParticipants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher.
- No Intervention: Control GroupNo Intervention is administered during the 2 months between Assessments
Primary Outcome Measure
Limb Motion Analysis [ Time Frame: Baseline, 10 weeks post treatment ]
Central Contacts
- Krissy Hansen, PT, ATP216-957-3584
- Tom Nown
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | Megan Moynahan (PRINCIPAL_INVESTIGATOR) |
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