Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT06734026
Status
Recruiting

Conditions

  • Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cafe Therapy — 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

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,

Key Dates

Start date
Apr 8, 2025
Status verified
Feb 2026
Primary completion
Jan 15, 2028
Completion
Jan 15, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
KIm Walsh, OT
216-957-3512
Krissy Hansen, PT, ATP
216-957-3584
Megan Moynahan (PRINCIPAL_INVESTIGATOR)

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