RECRUITING

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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,

Official Title

Multimodal, Enriched Environment for Rehabilitation

Quick Facts

Study Start:2025-02-15
Study Completion:2029-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06734026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * moderate to severe neurological diagnosis as diagnosed by a clinician,
  2. * ability to comprehend multi step instructions,
  3. * ability to independently balance with weight support,
  4. * physical deficits resulting in need for additional functional goals,
  5. * ability to endure 2 hours of weight-supported standing,
  6. * ability to provide informed consent,
  7. * basic communication ability,
  8. * currently discharged from therapy,
  9. * \>3 months post-injury,
  10. * \>18 years of age at time of enrollment
  1. * Adults unable to consent
  2. * Individuals who are not yet adults (infants, children, teenagers)
  3. * Non-English speaking
  4. * Pregnant women
  5. * Prisoners
  6. * Medical instability
  7. * Other neurological conditions
  8. * Severe problems with maintaining follow-up expected (such as, but not limited to history of substance abuse, homelessness/incarceration, dementia and psychotic disorders)

Contacts and Locations

Study Contact

Krissy Hansen, PT, ATP
CONTACT
216-957-3584
khansen1@metrohealth.org
Tom Nown
CONTACT
tnown@metrohealth.org

Principal Investigator

James Sulzer, PhD
PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center

Study Locations (Sites)

MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • James Sulzer, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-15
Study Completion Date2029-01-15

Study Record Updates

Study Start Date2025-02-15
Study Completion Date2029-01-15

Terms related to this study

Keywords Provided by Researchers

  • TBI
  • Brain injury
  • Traumatic Brain Injury

Additional Relevant MeSH Terms

  • Traumatic Brain Injury (TBI) Patients