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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New treatment protocol | Other | 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. |
| 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 |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rotem Eliav | Contact | +972543020023 | rotemeliav1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rotem Eliav | Loewenstein Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loewenstein Rehabilitation Hospital | Recruiting | Raanana | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38375580 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Conventional therapy | Other | conventional therapy |
|
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 |
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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |