Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 5, 2023
October 1, 2023
3.8 years
March 1, 2020
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Cognitive Self Efficacy Questionnaire II (CSEQ)
15 minutes
Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)
15 minutes
Mayo-Portland Adaptability Inventory - 4 (MPAI-4)
15 minutes
Quality of Life After Brain Injury (QOLIBRI)
15 minute
WebNeuro neurocognitive assessment battery
30 minutes
Other Outcomes (2)
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
30 minutes
Functional Independence Measure (FIM)
15 minutes
Study Arms (2)
Experimental Group
EXPERIMENTALIntervention 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.
Control group
ACTIVE COMPARATORIntervention 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- epilepsy
- history of drug use
- other psychiatric or neurologic disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loewenstein Rehabilitation Hospital
Raanana, Israel
Related Publications (1)
Eliav R, Nadler Tzadok Y, Segal-Rotenberg S, Kizony R. Efficacy of Intervention of Participation and Executive Functions (I-PEX) for Adults Following Traumatic Brain Injury: A Preliminary Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2024 Apr;38(4):279-290. doi: 10.1177/15459683241231529. Epub 2024 Feb 20.
PMID: 38375580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rotem Eliav
Loewenstein Rehabilitation Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Occupational therapist
Study Record Dates
First Submitted
March 1, 2020
First Posted
March 3, 2020
Study Start
March 1, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
October 5, 2023
Record last verified: 2023-10