Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

NCT06734026 | Recruiting

• 2 other identifiers: Study00000332HD116036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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,

Conditions

Traumatic Brain Injury (TBI) Patients

Keywords

TBI; Brain injury; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Limb Motion Analysis

  Preprocessing of data will be performed, and motion data will then be extracted. We will evaluate motion by single limb, namely: right arm, right leg, left arm, left leg. We will also combine across limbs: right arm, left arm, right leg, left leg, and over the whole-body amount of motion (AoM).

  Baseline, 10 weeks post treatment

Secondary Outcomes (3)

• 10 Meter Walk Test (10-MWT)

  Baseline, 10 weeks post treatment

• Action Research Arm Test (ARAT)

  Baseline, 10 weeks post treatment

• Neuro - Qol(Quality of Life)

  Baseline, 10 weeks post treatment

Study Arms (2)

Cafe Therapy

EXPERIMENTAL

Participants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher.

Behavioral: Cafe Therapy

Control Group

NO INTERVENTION

No Intervention is administered during the 2 months between Assessments

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.

Cafe Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• James Sulzer, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krissy Hansen, PT, ATP

CONTACT

216-957-3584; khansen1@metrohealth.org

Tom Nown

CONTACT

tnown@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 13, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)