What this study is
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,
What's being tested
- Cafe Therapy
Intervention · BEHAVIORAL
Participants 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
- Official title
- Multimodal, Enriched Environment for Rehabilitation
- Sponsor
- MetroHealth Medical Center
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Enrolling
- 20 people
- Starts
- 2025-04-08
- Est. completion
- 2029-01-15
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMetroHealth Medical Center
Cleveland, Ohio, United States
- KIm Walsh, OT · Contact216-957-3512kwalsh3@metrohealth.org
- Krissy Hansen, PT, ATP · Contact216-957-3584khansen1@metrohealth.org
- Megan Moynahan · Principal investigator
Recruiting
Study team
Sponsor
MetroHealth Medical Center
Study ID Study00000332
Principal investigator
James Sulzer, PhD
MetroHealth Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.