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Search / Trial NCT06734026

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Launched by METROHEALTH MEDICAL CENTER · Dec 10, 2024

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

Tbi Brain Injury Traumatic Brain Injury

ClinConnect Summary

This clinical trial is looking to see if a special rehabilitation program called the Metro Café can help people recover better from chronic traumatic brain injuries (TBI) compared to traditional therapy. The Metro Café is an enhanced environment where participants will engage in various activities like serving drinks and snacks, which aim to improve their speech, thinking skills, and movement in their arms and legs. The study will track how much therapy each participant receives during these sessions and how this impacts their overall recovery.

To be eligible for the trial, participants should be adults aged 18 and older who have moderate to severe brain injuries, can follow multi-step instructions, and can stand with some support for up to two hours. They also need to have been discharged from therapy for at least three months. Participants will take part in 18 training sessions over two months, attending three times a week for up to two hours each time. It’s important to note that individuals with certain conditions, such as severe medical issues or those who cannot provide consent, will not be eligible to participate.

Gender

ALL

Eligibility criteria

  • 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)

About Metrohealth Medical Center

MetroHealth Medical Center is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent sponsor, MetroHealth collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. With a commitment to ethical research practices and participant safety, the center leverages its extensive resources and expertise to contribute to the scientific community and enhance healthcare outcomes. Through rigorous clinical trials, MetroHealth aims to translate research findings into tangible benefits for patients, fostering a culture of excellence in clinical research.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

James Sulzer, PhD

Principal Investigator

MetroHealth Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported