Cafe Therapy for Traumatic Brain Injury

Overseen By Tom Nown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Non-English, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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,

Research Team

James Sulzer, PhD

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for individuals with chronic traumatic brain injury who are seeking to improve their recovery outcomes. Participants will engage in a unique 'Cafe Therapy' during the study, which involves serving customers and performing tasks in a simulated cafe environment.

Inclusion Criteria

I have been discharged from my recent therapy.

Ability to comprehend multi-step instructions

I can stand up with some support.

Exclusion Criteria

Medical instability

Prisoners

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Metro Café therapy sessions, performing tasks such as serving customers and maintaining supplies, 3 times per week for 2 months

8 weeks

18 visits (in-person)

Control

Participants in the control group do not receive any intervention during the 2 months between assessments

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including functional assessments and surveys

10 weeks

Treatment Details

Interventions

• Cafe Therapy

Trial Overview The study tests if an enriched environment called Metro Café, offering multi-modal therapy (combining speech, cognition, and physical movement therapies), leads to better recovery than traditional methods. It measures therapy dosage and its correlation with clinical outcomes.

Participant Groups

Group I: Cafe Therapy Experimental Treatment 1 Intervention

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

Group II: Control Group Active Control 1 Intervention

No Intervention is administered during the 2 months between Assessments

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+