Traumatic Brain InjuryNCT06080269
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 study testing technology based intervention along with conventional therapy and conventional therapy alone in people with Traumatic Brain Injury, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. 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?
- technology based intervention along with conventional therapy and conventional therapy alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteQatar
- Study dates
- 25 May 2022to 30 Dec 2024
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Qatar Rehabilitation Institute, Hamad Medical Corporation
Doha, 3050
Reetha J Sureka, MOT, 40260257 ext. 974, rsukumaran3@hamad.qa
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- technology based intervention along with conventional therapy, conventional therapy alone
- Keywords
- Traumatic Brain Injury Rehabilitation, Technology based intervention, Cognitive retraining, Executive functions
- 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.
technology based intervention along with conventional therapyDevice
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.
conventional therapy aloneOther
Participants in the control group will receive only conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The participants in the intervention arm will be receiving technology based training along with the conventional therapy Receives: 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 Receives: Other: conventional therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 times, one before the intervention and one after 6 weeks
Secondary outcomes (2)
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.
Measured: 2 times, one before the intervention and one after 6 weeks
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.
Measured: 2 times, one before the intervention and one after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start25 May 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Intervention and control group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080269
- Sponsor's protocol ID
- MRC-01-21-857
- Status last verified
- Jun 2023
- First submitted
- 27 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' identity will not be revealed. The data will be coded and will be sent to other researchers for analysis purpose.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06080269
- Acronym / sponsor ID
- MRC-01-21-857
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury Rehabilitation, Technology based intervention, Cognitive retraining, Executive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: technology based intervention along with conventional therapyThe participants in the intervention arm will be receiving technology based training along with the conventional therapy |
| Control arm | Active comparator | Other: conventional therapy aloneThe participants in the control arm will be receiving the regular conventional therapy program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| technology based intervention along with conventional therapyTechnology based intervention are training session given to the participants through devices which has software installed to train cognitive functions for patients with cognitive deficit. | Device | Intervention arm |
| conventional therapy aloneParticipants in the control group will receive only conventional therapy | Other | Control arm |
Primary outcome
Executive Function Performance Test (EFPT)
Time frame: 2 times, one before the intervention and one after 6 weeks
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 secondary outcomes
Cognitive functional independence measure scale (CogFIM)
Time frame: 2 times, one before the intervention and one after 6 weeks
Mini Mental State Examination -2 (MMSE-2)
Time frame: 2 times, one before the intervention and one after 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No. Patients' identity will not be revealed. The data will be coded and will be sent to other researchers for analysis purpose.
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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.
Qatar Rehabilitation Institute, Hamad Medical Corporation
Doha, Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing technology based intervention along with conventional therapy and conventional therapy alone in people with Traumatic Brain Injury, run by Hamad Medical Corporation at 1 site in Qatar.
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 5 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 12 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 Qatar. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function Performance Test (EFPT) (time frame: 2 times, one before the intervention and one after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.