Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

NCT ID: NCT06734026

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2029-01-15

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,

Detailed Description

People who have had a brain injury and their caregiver, are being asked to participate in this study. After a brain injury it is a common to have cognitive and physical limitations. These problems can lead to the inability to care for yourself, lack of motivation, isolation, and loss of employment. Therapies are commonly prescribed to address these issues. The standard of care is to prescribe physical, occupational and speech therapy. If you are thinking about this study, you have probably tried some of these treatments. Therapies typically address walking, balance, reaching and grasping as well as problem-solving and memory, with the goal to complete as many repetitions of the activities as possible to improve your overall function. However, this therapy does not always address real life activities.

We have developed an enhanced environment for multimodal therapy called "The Metro Café." This is a free-standing frame on an adjustable body weight support system which allows you to move in a small area. The harness wraps around your torso and is attached to an overhead frame to prevent falls and reduce some of your weight making mobility easier. Participants in this portion of the study will operate a small Café serving food and drinks. The goal of this therapy is for participants to practice job activities that involve motor, social and cognitive skills.

The purpose of this study is to determine if a multimodal approach (an approach that combines several different therapies) to therapy results in improved outcomes for recovery after a brain injury.

Participants assigned to the Metro Cafe treatment will work in a cafe setting 3x/week for 2 months. 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.

Some participants will not receive treatment and will only complete the study Assessments.

Participants and Caregiver will complete Survey before and after the treatment. Participants will also complete functional assessments of Upper and Lower extremity function, gait and balance.

Conditions

Traumatic Brain Injury (TBI) Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cafe Therapy

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

Group Type: EXPERIMENTAL

Cafe Therapy

Intervention Type: 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.

Control Group

No Intervention is administered during the 2 months between Assessments

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cafe Therapy

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Sulzer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Sulzer, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Krissy Hansen, PT, ATP

Role: CONTACT

khansen1@metrohealth.org

216-957-3584

Tom Nown

Role: CONTACT

tnown@metrohealth.org

Facility Contacts

KIm Walsh, OT

Role: primary

kwalsh3@metrohealth.org

216-957-3512

Krissy Hansen, PT, ATP

Role: backup

khansen1@metrohealth.org

216-957-3584

Other Identifiers

HD116036

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Study00000332

Identifier Type: -

Identifier Source: org_study_id