Enhanced environment therapy for recovery in chronic traumatic brain injury
Multimodal, Enriched Environment for Rehabilitation
This study tests if a new therapy program where people with chronic traumatic brain injury run a café can help them improve their thinking, social, and movement skills better than regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06734026 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a multimodal therapy approach in an enriched environment called the Metro Café for individuals with chronic traumatic brain injury (TBI). Participants will engage in various therapeutic activities while operating a café, which includes serving food and drinks, to improve their cognitive, social, and motor skills. The study will compare outcomes between those receiving Metro Café therapy and those receiving standard care, focusing on therapy dosage and clinical outcomes. The intervention consists of 18 training sessions over two months, each lasting up to two hours.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with moderate to severe TBI who have been discharged from therapy and can follow multi-step instructions.
Not a fit: Patients who are unable to provide informed consent, non-English speakers, or those with severe medical instability or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery outcomes for patients with chronic TBI by providing a more engaging and practical therapeutic environment.
How similar studies have performed: While similar multimodal approaches have shown promise in rehabilitation, this specific enriched environment therapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * moderate to severe neurological diagnosis as diagnosed by a clinician, * ability to comprehend multi step instructions, * ability to independently balance with weight support, * physical deficits resulting in need for additional functional goals, * ability to endure 2 hours of weight-supported standing, * ability to provide informed consent, * basic communication ability, * currently discharged from therapy, * \>3 months post-injury, * \>18 years of age at time of enrollment Exclusion Criteria: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Non-English speaking * Pregnant women * Prisoners * Medical instability * Other neurological conditions * Severe problems with maintaining follow-up expected (such as, but not limited to history of substance abuse, homelessness/incarceration, dementia and psychotic disorders)
Where this trial is running
Cleveland, Ohio
- MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: James Sulzer, PhD — MetroHealth Medical Center
- Study coordinator: Krissy Hansen, PT, ATP
- Email: khansen1@metrohealth.org
- Phone: 216-957-3584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.