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Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

N/A
Waitlist Available
Led By James Sulzer, PhD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* moderate to severe neurological diagnosis as diagnosed by a clinician
* ability to comprehend multi step instructions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 weeks post treatment
Awards & highlights
No Placebo-Only Group

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,

Eligible Conditions
  • Traumatic Brain Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Limb Motion Analysis
Secondary study objectives
10 Meter Walk Test (10-MWT)
Action Research Arm Test (ARAT)
Neuro - Qol(Quality of Life)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cafe TherapyExperimental Treatment1 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 GroupActive Control1 Intervention
No Intervention is administered during the 2 months between Assessments

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
120 Previous Clinical Trials
22,056 Total Patients Enrolled
James Sulzer, PhDPrincipal InvestigatorMetroHealth Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
~13 spots leftby Jan 2028