Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
Primary Purpose
Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
New treatment protocol
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Executive functions, cognitive, sub-acute, rehabilitation
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).
Exclusion Criteria:
- epilepsy
- history of drug use
- other psychiatric or neurologic disorder.
Sites / Locations
- Loewenstein Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
WebNeuro neurocognitive assessment battery
A web-based computerized battery of neurocognitive functioning.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04292925
Brief Title
Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
Official Title
Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Executive functions, cognitive, sub-acute, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
New treatment protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
conventional therapy
Primary Outcome Measure Information:
Title
The Multiple Errands Test - the hospital version (MET-HV)
Description
A performance-based assessment which was design to assess the effect of EF deficits on everyday functioning.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Cognitive Self Efficacy Questionnaire II (CSEQ)
Description
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.
Time Frame
15 minutes
Title
Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)
Description
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.
Time Frame
15 minutes
Title
Mayo-Portland Adaptability Inventory - 4 (MPAI-4)
Description
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.
Time Frame
15 minutes
Title
Quality of Life After Brain Injury (QOLIBRI)
Description
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).
Time Frame
15 minute
Title
WebNeuro neurocognitive assessment battery
Description
A web-based computerized battery of neurocognitive functioning.
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Description
The LOTCA was designed to give a preliminary cognitive profile for patients with an acquired head injury
Time Frame
30 minutes
Title
Functional Independence Measure (FIM)
Description
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).
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Exclusion Criteria:
epilepsy
history of drug use
other psychiatric or neurologic disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rotem Eliav
Phone
+972543020023
Email
rotemeliav1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rotem Eliav
Organizational Affiliation
Loewenstein Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loewenstein Rehabilitation Hospital
City
Ra'anana
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rotem Eliav, M.Sc.OT
Phone
+972543020023
Email
rotemeliav1@gmail.com
12. IPD Sharing Statement
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Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
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