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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: New treatment protocol
* Other: Conventional therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* 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.<br>|
| Active Comparator: Control group<br>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<br>* conventional therapy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Executive functions, cognitive, sub-acute, rehabilitation