NCT06734026 · MetroHealth Medical Center
Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations