Traumatic Brain Injury (TBI) PatientsNCT06734026
Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
A study testing Cafe Therapy in people with Traumatic Brain Injury (TBI) Patients, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- What is being tested?
- Cafe Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 15 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- basic communication ability,
- currently discharged from therapy,
- >3 months post-injury,
- >18 years of age at time of enrollment
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tom Nown contact
United States1 site, 1 recruiting
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
KIm Walsh, OT, 216-957-3512, kwalsh3@metrohealth.org
Krissy Hansen, PT, ATP, 216-957-3584, khansen1@metrohealth.org
About this study
Official title: Multimodal, Enriched Environment for Rehabilitation
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,
Read the 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
- Being tested
- Cafe Therapy
- Keywords
- TBI, Brain injury, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cafe TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cafe Therapy |
| Control Group | No intervention | No Intervention is administered during the 2 months between Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 10 weeks post treatment
Secondary outcomes (3)
10 Meter Walk Test (10-MWT)
The total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/seconds
Measured: Baseline, 10 weeks post treatment
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is a 19-item measure aimed at assessing functional performance of the upper extremity through observational means.
Measured: Baseline, 10 weeks post treatment
Neuro - Qol(Quality of Life)
The NeuroQOL is a self-report of health related quality of life in 17 domains and sub-domains for adults and 11 for children with neurological disorders. The measure is available for administration via Computer Assisted Testing or in short forms (8-10 items) for each sub-domain that can be selected based on individual patient needs:
- Neuro-QoL - Positive Affect and Well-Being the following Domains will be used:
- Neuro-QoL - Lower Extremity Function
- Neuro-QoL - Upper Extremity Function
- Neuro-QoL - Sleep Disturbance
- Neuro-QoL - Emotional and Behavioral Dyscontrol
- Neuro-QoL - Fatigue
- Neuro-QoL - Stigma
Scale 1-5 (lower score better outcome)
- - Never
- - Rarely
- - Sometimes
- - Often
- - Always
Measured: Baseline, 10 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start8 Apr 2025
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Sulzer, MetroHealth Medical Center
- Investigators
- James Sulzer, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734026
- Sponsor's protocol ID
- Study00000332
- Other IDs
- HD116036
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make the IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal, Enriched Environment for Rehabilitation
- ClinicalTrials.gov ID
- NCT06734026
- Acronym / sponsor ID
- Study00000332
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Keywords
- TBI, Brain injury, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cafe Therapy | Experimental | Behavioral: Cafe TherapyParticipants will be volunteer workers for two hours per day, three days per week for 6-8 weeks, alongside a trained researcher. |
| Control Group | No intervention | –No Intervention is administered during the 2 months between Assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (8 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Non-English speaking
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cafe TherapyParticipants 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. | Behavioural | Cafe Therapy |
Primary outcome
Limb Motion Analysis
Time frame: Baseline, 10 weeks post treatment
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).
3 secondary outcomes
10 Meter Walk Test (10-MWT)
Time frame: Baseline, 10 weeks post treatment
Action Research Arm Test (ARAT)
Time frame: Baseline, 10 weeks post treatment
Neuro - Qol(Quality of Life)
Time frame: Baseline, 10 weeks post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. There is not a plan to make the IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Nown contact
James Sulzer, PhD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cafe Therapy in people with Traumatic Brain Injury (TBI) Patients, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krissy Hansen, PT, ATP (216-957-3584, khansen1@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Motion Analysis (time frame: Baseline, 10 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.