Clinical trial NCT04292925: Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
Official title: Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Executive functions
cognitive
sub-acute
rehabilitation
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To examine the feasibility of a new treatment protocol in improving executive function deficits and participation in daily activities of adults with TBI at discharge and one month post-discharge.

A double-blind (assessors) randomized control trial (RCT) with two groups, experimental and control.

This study will include 40 adults hospitalized in the inpatient Head Trauma unit.

Potential patients will be approached by occupational therapists working in the inpatient Head Trauma rehabilitation unit and be invited to participate in the study. If they agree, they will be asked to sign an informed consent form. Then they will undergo a screening assessment. Participants who are found eligible will be then administered a cognitive assessment battery. Then they will be randomly allocated to either the experimental (new treatment protocol) or the control (conventional therapy) group. In both groups, the intervention will include 18 treatment sessions of 45 minutes, between three to five times a week depending on the participant's state, over a period of four to six weeks. Following the intervention, participants will undergo the assessment again. Participation questionnaires will be administered by telephone one month post-discharge.

Detailed description: A double-blind randomized control trial (RCT) with two groups, experimental and control.

This study will include 40 adults hospitalized in the inpatient Head Trauma unit.

Potential patients will be approached by occupational therapists working in the inpatient Head Trauma rehabilitation unit and be invited to participate in the study. If they agree, they will be asked to sign an informed consent form. Then they will undergo a screening assessment. Participants who are found eligible will be then administered a cognitive assessment battery. Then they will be randomly allocated to either the experimental (new treatment protocol) or the control (conventional therapy) group. In both groups, the intervention will include 18 treatment sessions of 45 minutes, between three to five times a week depending on the participant's state, over a period of four to six weeks. Following the intervention, participants will undergo the assessment again. Participation questionnaires will be administered by telephone one-month post-discharge.

Eligibility 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.

Primary outcomes:
measure: The Multiple Errands Test - the hospital version (MET-HV)
timeFrame: 30 minutes
Secondary outcomes:
measure: Cognitive Self Efficacy Questionnaire II (CSEQ)
timeFrame: 15 minutes
measure: Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)
timeFrame: 15 minutes
measure: Mayo-Portland Adaptability Inventory - 4 (MPAI-4)
timeFrame: 15 minutes
measure: Quality of Life After Brain Injury (QOLIBRI)
timeFrame: 15 minute
measure: WebNeuro neurocognitive assessment battery
timeFrame: 30 minutes
Other outcomes:
measure: Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
timeFrame: 30 minutes
measure: Functional Independence Measure (FIM)
timeFrame: 15 minutes
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Hospital
Study officials:
affiliation: Loewenstein Rehabilitation Hospital
name: Rotem Eliav
role: PRINCIPAL_INVESTIGATOR
References: