Actively Recruiting
Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
Led by MetroHealth Medical Center · Updated on 2026-03-03
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if an enhanced environment called the Metro Café, which uses a multimodal approach combining several therapies, improves recovery outcomes better than traditional therapy for people with chronic traumatic brain injury. The study focuses on measuring therapy dosage involving speech, cognition, and limb movements during Metro Café sessions and how this relates to clinical outcomes. It compares participants receiving Metro Café therapy to those who do not to see if function improves more with this treatment. Participants assigned to the Metro Café group will act as volunteer workers in a café setting for two hours a day, three days a week, over 6 to 8 weeks, completing at least 18 sessions. They will greet and serve customers, manage food supplies, and perform housekeeping tasks with help from a supervising researcher. One session per week includes guidance and direction from a therapist. The control group will not receive treatment during the 2-month period between assessments and will only complete study assessments. During the study, both participants and their caregivers will complete surveys before and after treatment. Participants will also undergo functional assessments of upper and lower limb function, gait, and balance at the start and about 10 weeks after treatment. The main outcome measured is limb motion analysis. Secondary outcomes include walking speed, arm function tests, and quality of life assessments. The study runs from April 2025 to January 2029 and is sponsored by MetroHealth Medical Center.
CONDITIONS
Brief Title
Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 requiring additional functional goals
- Ability to endure 2 hours of weight-supported standing
- Ability to provide informed consent
- Basic communication ability
- Currently discharged from therapy
- More than 3 months post-injury
- 18 years of age or older at time of enrollment
You will not qualify if you...
- Unable to provide informed consent
- Under 18 years of age
- Non-English speaking
- Pregnant women
- Prisoners
- Medical instability
- Other neurological conditions
- Severe problems maintaining follow-up (such as history of substance abuse, homelessness, incarceration, dementia, or psychotic disorders)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 8 weeks
Participants work in a café setting practicing job activities that involve motor, social, and cognitive skills with supervision, three times per week for 2 hours each session.
3 visits per week for 6 to 8 weeks
Duration - Approximately 10 weeks post-treatment
Participants complete assessments of functional outcomes and quality of life approximately 10 weeks after treatment ends.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
K
Krissy Hansen, PT, ATP
T
Tom Nown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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