To Compare the Effect of Receiving the Technology-based Training Along With the Conventional Therapy to the Conventional Therapy Alone on Executive Functions Among People With Traumatic Brain Injury With Mild to Moderate Cognitive Deficit

NCT06080269 | Unknown DMC

• 1 other identifier: MRC-01-21-857
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effect of receiving the technology-based training along with the conventional therapy to the conventional therapy alone on executive functions among people with traumatic brain injury with mild to moderate cognitive deficit. It aims to answer:

• If there is significant improvement in executive function skills among people with traumatic brain injury receiving technology-based training along with conventional therapy when compared to people with traumatic brain injury receiving conventional therapy alone.
• To see if the demographic variable has any effect on the cognitive improvement Participants will in the intervention group will be given 45 minutes of extra training session using technology along with their usual rehabilitation session. And Participants in the control group will be receiving the usual rehabilitation sessions. Researchers will compare the changes in the outcome measures between the intervention and control group to see if the technology-based training along with conventional therapy had significant effect on executive skills among people with traumatic brain injury.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury Rehabilitation; Technology based intervention; Cognitive retraining; Executive functions

Outcome Measures

Primary Outcomes (1)

• Executive Function Performance Test (EFPT)

  It's a performance-based assessment that measures the executive functions. It has score ranging from 0 to 50, where higher the score higher is the executive skills

  2 times, one before the intervention and one after 6 weeks

Secondary Outcomes (2)

• Cognitive functional independence measure scale (CogFIM)

  2 times, one before the intervention and one after 6 weeks

• Mini Mental State Examination -2 (MMSE-2)

  2 times, one before the intervention and one after 6 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

The participants in the intervention arm will be receiving technology based training along with the conventional therapy

Device: technology based intervention along with conventional therapy

Control arm

ACTIVE COMPARATOR

The participants in the control arm will be receiving the regular conventional therapy program

Other: conventional therapy alone

Interventions

technology based intervention along with conventional therapy DEVICE

Technology based intervention are training session given to the participants through devices which has software installed to train cognitive functions for patients with cognitive deficit.

Intervention arm

conventional therapy alone OTHER

Participants in the control group will receive only conventional therapy

Control arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with traumatic brain injury i.e damage to the brain resulting from external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile
• Adults aged between 18 and 60 years old
• No previous history of head trauma
• With MMSE score \>10 and \< 23 (people with mild to moderate cognitive deficit)
• Ability to give consent and willingness to comply with cognitive rehabilitation program.

You may not qualify if:

• Pre-existing chronic illness that causes neurological symptoms or complications such as congenital disorder, history of stroke, tumor, brain infection or any other previous disorder due to brain damage affecting the cognition.
• History of any psychiatry disorders which affects the cognitive functions such as schizophrenia, bipolar disorder etc.
• Those who cannot follow basic simple instruction or comprehend simple commands

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Qatar Rehabilitation Institute, Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding was done hence its a open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention and control group

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 12, 2023
• Study Start: May 25, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)