Clinical trial NCT06734026: Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury
Official title: Multimodal, Enriched Environment for Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury (TBI) Patients
Keywords: TBI
Brain injury
Traumatic Brain Injury
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Limb Motion Analysis
timeFrame: Baseline, 10 weeks post treatment
Secondary outcomes:
measure: 10 Meter Walk Test (10-MWT)
timeFrame: Baseline, 10 weeks post treatment
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, 10 weeks post treatment
measure: Neuro - Qol(Quality of Life)
timeFrame: Baseline, 10 weeks post treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: James Sulzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: