Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation

Loewenstein Hospital1 site in 1 country40 target enrollmentMarch 1, 2020

ConditionsTraumatic Brain Injury

Overview

Phase: N/A
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: Loewenstein Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: The Multiple Errands Test - the hospital version (MET-HV)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2020

End Date

December 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Loewenstein Hospital

Responsible Party

Principal Investigator

Rotem Eliav

Occupational therapist

Loewenstein Hospital

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).