Improving daily activities for adults with traumatic brain injury during rehabilitation
Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation
This study is testing a new treatment to help adults with traumatic brain injury improve their daily activities during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Loewenstein Hospital Academic / other |
| Locations | 1 site (Ra'anana) |
| Trial ID | NCT04292925 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of a new treatment protocol designed to enhance executive function deficits and participation in daily activities among adults with traumatic brain injury (TBI) during sub-acute inpatient rehabilitation. The study will involve 40 participants who will be randomly assigned to either the experimental group receiving the new treatment or the control group receiving conventional therapy. Each participant will undergo a series of cognitive assessments before and after the intervention, which consists of 18 treatment sessions over four to six weeks. Follow-up assessments will be conducted one month post-discharge to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with mild to severe traumatic brain injury who have preserved basic cognitive abilities.
Not a fit: Patients with epilepsy, a history of drug use, or other psychiatric or neurologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive functioning and greater participation in daily activities for individuals recovering from traumatic brain injury.
How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in improving cognitive outcomes in TBI rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mild to severe TBI as diagnosed by a physician and confirmed by imaging * age 18-60 * able to understand instructions of assessment tools as will be determined by their Occupational Therapist * basic cognitive abilities preserved as will be determined by three subtests of the Loewenstein Occupational Therapy Cognitive Assessment: orientation (score: 6/8 or above), visual perception (score: 3/4 or above) and spatial perception (score: 2/4 or above) * at least one functional upper extremity as will be determined by their Occupational Therapist * intact or corrected vision. * a score of 1 or above in the The Multiple Errands Test - the hospital version (MET-HV). Exclusion Criteria: * epilepsy * history of drug use * other psychiatric or neurologic disorder.
Where this trial is running
Ra'anana
- Loewenstein Rehabilitation Hospital — Ra'anana, Israel (Recruiting)
Study contacts
- Principal investigator: Rotem Eliav — Loewenstein Rehabilitation Hospital
- Study coordinator: Rotem Eliav
- Email: rotemeliav1@gmail.com
- Phone: +972543020023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.