Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation

Loewenstein Hospital

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Conventional therapy; Other: New treatment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04292925

0028-18-LOE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Intervention with the new treatment protocol 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.

Treatment:

Other: New treatment protocol

Control group

Active Comparator group

Description:

Intervention with conventional therapy 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.

Treatment:

Other: Conventional therapy