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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: New treatment protocol; Other: Conventional therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rotem Eliav; Phone Number: +972543020023; Email: rotemeliav1@gmail.com

Study Locations

• Israel
  • Ra'anana, Israel
    • Recruiting
    • Loewenstein Rehabilitation Hospital
    • Contact: Rotem Eliav, M.Sc.OT; Phone Number: +972543020023; Email: rotemeliav1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Other: New treatment protocol; The new treatment protocol focuses on training of executive processes using remedial strategies and on promoting the use of meta-cognitive strategies. Goal directed activities are used to improve the underlying cognitive process and transfer of the learned skill to everyday function will be encouraged.
Active Comparator: Control group; 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.	Other: Conventional therapy; conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Multiple Errands Test - the hospital version (MET-HV)	A performance-based assessment which was design to assess the effect of EF deficits on everyday functioning.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Self Efficacy Questionnaire II (CSEQ)	The CSEQ is a questionnaire designed to assess a person's beliefs regarding their ability to recognize, monitor and manage cognitive symptoms and everyday challenging cognitive activities.	15 minutes
Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)	The SPIRQ is a 20 items questionnaire designed to measure clients' self-perceptions of injury, perceived benefits of rehabilitation, and emotional reactions throughout inpatient or outpatient rehabilitation.	15 minutes
Mayo-Portland Adaptability Inventory - 4 (MPAI-4)	The MPAI is designed to assist in the clinical evaluation of people during post acute period following traumatic brain injury, to assist in the evaluation of rehabilitation programs and to better understand the long-term outcomes of traumatic brain injury.	15 minutes
Quality of Life After Brain Injury (QOLIBRI)	Is a questionnaire designed to assess quality of life following traumatic brain injury. The QOLIBRI instrument consists of 37 items in four satisfaction scales, ''Cognition'' (7 items), ''Self'' (7 items), ''Daily Life and Autonomy'' (7 items), and ''Social Relationships'' (6 items), and two bothered scales, ''Emotions'' (5 items) and ''Physical Problems'' (5 items).	15 minute
WebNeuro neurocognitive assessment battery	A web-based computerized battery of neurocognitive functioning.	30 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)	The LOTCA was designed to give a preliminary cognitive profile for patients with an acquired head injury	30 minutes
Functional Independence Measure (FIM)	The FIM instrument is designed to assess functional independence. The FIM consists of 18 items which are divided into six subscales (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Each of the 18 items have a maximum score of 7 (complete independence) and a minimum score of 1 (complete dependence), thus possible scores range from 18 to 126 (Donaghy & Wass, 1998).	15 minutes

Collaborators and Investigators

• Sponsor: Loewenstein Hospital
• Investigators: Principal Investigator: Rotem Eliav, Loewenstein Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; Executive functions; cognitive; sub-acute
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 0028-18-LOE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No