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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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
technology based intervention along with conventional therapy
conventional therapy alone
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury Rehabilitation, Technology based intervention, Cognitive retraining, Executive functions

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Qatar Rehabilitation Institute, Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cognitive functional independence measure scale (CogFIM)
Functional Independence measure is a test that evaluated the participants independence in functional activities and CogFIM measure the independence in social cognition. The score ranges from 0 to 35, where higher the scores indicates higher is the social cognitive skills.
Mini Mental State Examination -2 (MMSE-2)
It's a tool to measure the general cognitive functions of the participants. This tool can be used as a screening tool and as an outcome tool. The score ranges from 0 to 30 where higher the score higher is the general cognition.

Full Information

First Posted
September 27, 2023
Last Updated
October 10, 2023
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT06080269
Brief Title
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
Official Title
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: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cognitive deficit following traumatic brain injury is one of the important consequences affecting the individual's quality of life. Various cognitive intervention strategies are in practice and the use of technology-based cognitive interventions are into current practice. This study is a Pilot Randomized Control Trial which aims 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. This study will be done in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. People with traumatic brain injury with mild to moderate cognitive deficit (MMSE>10 and <23), between the age group of 18 to 60 years, no previous history of head trauma and willing to comply with cognitive rehabilitation program will be recruited for this study. The investigators will be explaining the details of the study to the participants and the participants who are willing to take part in the study had to give their consent by signing the consent sheet. After which they will be randomized in either intervention or control group through envelop concealment method. After randomization, the participants will be assessed using the outcome measures such as MMSE, Cognitive FIM and Executive function performance test (EFPT), one day before the start of the intervention. Participants in the intervention group will be receiving extra 45 min of technology based cognitive circuit training using MYRO, BITS and Cognitive Rehametrics in addition to the conventional therapy and participants in the control group will be receiving the regular conventional therapy alone. As a part of conventional therapy, participants will be receiving an hour of occupational therapy which focuses on all aspects of the deficit. For cognitive deficit, the participants will be receiving traditional method of training that includes paper pencil task, tabletop activities, performance-based activities and computer-based activities. Participants in both the groups will be receiving the sessions 5 times a week for 6 weeks. At the end of 6 weeks, all the participants in both groups will be assessed using the outcome measures, and the data will be collated, coded and entered in an excel sheet. The coded data will be sent for the statistical analysis. Baseline characteristics will be presented as means±SD or median for continuous data, and as frequencies and associated percentages for categorical parameters. The statistical P value for change from baseline for quantitative outcomes will be calculated with a paired test or Wilcoxon signed rank test, and the P value for the difference between intervention and control groups will be calculated using unpaired t or Mann Whitney U tests appropriate. Associations between two or more qualitative variables will be assessed using Chi-square (χ2) or Fisher Exact tests as appropriate. Relationship between two quantitative variables (age, EFPT, FIM scores etc.) will be examined using Pearson's or Spearman's correlation coefficients. All primary efficacy analyses will be performed on the intent-to-treat (ITT) population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury Rehabilitation, Technology based intervention, Cognitive retraining, Executive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and control group
Masking
None (Open Label)
Masking Description
No blinding was done hence its a open label study
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
The participants in the intervention arm will be receiving technology based training along with the conventional therapy
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
The participants in the control arm will be receiving the regular conventional therapy program
Intervention Type
Device
Intervention Name(s)
technology based intervention along with conventional therapy
Intervention Description
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 Type
Other
Intervention Name(s)
conventional therapy alone
Intervention Description
Participants in the control group will receive only conventional therapy
Primary Outcome Measure Information:
Title
Executive Function Performance Test (EFPT)
Description
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
Time Frame
2 times, one before the intervention and one after 6 weeks
Secondary Outcome Measure Information:
Title
Cognitive functional independence measure scale (CogFIM)
Description
Functional Independence measure is a test that evaluated the participants independence in functional activities and CogFIM measure the independence in social cognition. The score ranges from 0 to 35, where higher the scores indicates higher is the social cognitive skills.
Time Frame
2 times, one before the intervention and one after 6 weeks
Title
Mini Mental State Examination -2 (MMSE-2)
Description
It's a tool to measure the general cognitive functions of the participants. This tool can be used as a screening tool and as an outcome tool. The score ranges from 0 to 30 where higher the score higher is the general cognition.
Time Frame
2 times, one before the intervention and one after 6 weeks

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: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Qatar Rehabilitation Institute, Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reetha J Sureka, MOT
Phone
40260257
Ext
974
Email
rsukumaran3@hamad.qa

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patients' identity will not be revealed. The data will be coded and will be sent to other researchers for analysis purpose.

Learn more about this trial

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

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