Recruiting

Rehabilitation

Sponsor:

MetroHealth Medical Center

Code:

NCT06734026

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cafe Therapy

Study Details

Brief summary:

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,

Conditions

Traumatic Brain Injury (TBI) Patients

Study ID

NCT06734026

Start date

Apr 8, 2025

Status verified date

Feb, 2026

Completion date

Jan 15, 2029

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cafe Therapy

Participants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher.

no intervention: Control Group

No Intervention is administered during the 2 months between Assessments

Interventions

Cafe Therapy

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.

Primary outcome measure

  • Limb Motion Analysis [ Time Frame: Baseline, 10 weeks post treatment ]

Central Contacts and Locations

Central contacts

Krissy Hansen, PT, ATP

216-957-3584khansen1@metrohealth.org

Tom Nown

tnown@metrohealth.org

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

KIm Walsh, OT

216-957-3512kwalsh3@metrohealth.org

Krissy Hansen, PT, ATP

216-957-3584khansen1@metrohealth.org

Principal Investigator:

Megan Moynahan

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • TBI
  • Brain injury
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2026-03-03.