Traumatic Brain InjuryNCT04292925
Participation and Executive Functions in Adults Following Traumatic Brain Injury In Sub-Acute Inpatient Rehabilitation
A study testing New treatment protocol and Conventional therapy in people with Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- New treatment protocol and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- epilepsy
- history of drug use
- other psychiatric or neurologic disorder.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Hospital
Raanana
Rotem Eliav, M.Sc.OT, +972543020023, rotemeliav1@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- New treatment protocol, Conventional therapy
- Keywords
- Executive functions, cognitive, sub-acute, rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New treatment protocolOther
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.
Conventional therapyOther
conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: New treatment protocol |
| 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. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 15 minute
WebNeuro neurocognitive assessment battery
A web-based computerized battery of neurocognitive functioning.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Mar 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rotem Eliav, Loewenstein Hospital
- Investigators
- Rotem Eliav, Principal investigator, Loewenstein Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292925
- Sponsor's protocol ID
- 0028-18-LOE
- Status last verified
- Oct 2023
- First submitted
- 1 Mar 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38375580
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04292925
- Acronym / sponsor ID
- 0028-18-LOE
- Conditions
- Traumatic Brain Injury
- Keywords
- Executive functions, cognitive, sub-acute, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: New treatment protocolIntervention 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 | Other: Conventional therapyIntervention 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- epilepsy
- history of drug use
- other psychiatric or neurologic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New treatment protocolThe 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. | Other | Experimental Group |
| Conventional therapyconventional therapy | Other | Control group |
Primary outcome
The Multiple Errands Test - the hospital version (MET-HV)
Time frame: 30 minutes
A performance-based assessment which was design to assess the effect of EF deficits on everyday functioning.
5 secondary outcomes
Cognitive Self Efficacy Questionnaire II (CSEQ)
Time frame: 15 minutes
Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)
Time frame: 15 minutes
Mayo-Portland Adaptability Inventory - 4 (MPAI-4)
Time frame: 15 minutes
Quality of Life After Brain Injury (QOLIBRI)
Time frame: 15 minute
WebNeuro neurocognitive assessment battery
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 38375580Eliav 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rotem Eliav principal investigator
Loewenstein Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New treatment protocol and Conventional therapy in people with Traumatic Brain Injury, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rotem Eliav (+972543020023, rotemeliav1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Multiple Errands Test - the hospital version (MET-HV) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.