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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292925
• Other study ID #: 0028-18-LOE
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Loewenstein Hospital
• Contact: Rotem Eliav
• Phone: +972543020023
• Email: rotemeliav1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• New treatment protocol
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 therapy
conventional therapy

Locations

Country	Name	City	State
Israel	Loewenstein Rehabilitation Hospital	Ra'anana

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Functional Independence Measure (FIM)	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	WebNeuro neurocognitive assessment battery	A web-based computerized battery of neurocognitive functioning.	30 minutes