Traumatic Brain InjuryImpact TBINCT07612410
Impact of Traumatic Brain Injury on Cognitive Function, Balance and Functional Independence in Children
An observational study of Traumatic Brain Injury, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the impact of different levels of traumatic brain injury on cognitive function, functional independence and balance on children and relation of cognitive dysfunction, balance disturbance and functional independence Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 24 children with traumatic brain injury from both sexes will participate in this study and 24 normal volunteer children for age matching group.
Who may be able to join
- Children diagnosed with mild to moderate traumatic brain injury.
- Their chronological age will be ranged from 8 years to 12 years.
- All subjects medically controlled immediately after discharge.
Who cannot join
- children with other neurological impairments or epilepsy.
- Visual or hearing impairment
- Motor or behavioral disorders before trauma such as Developmental Coordination Disorder (DCD) or Attention Deficit Hyperactive Disorder (ADHD).
- Receiving medical drugs that can cause confusion or make child less alert.
- any chronic diseases as cardiac or lung disease.
- musculoskeletal contracture or disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Traumatic Brain Injury on Cognitive Function, Balance and Functional Lndependence in Children
The purpose of the study is to determine the impact of different levels of traumatic brain injury on cognitive function, functional independence and balance on children and relation of cognitive dysfunction, balance disturbance and functional independence
Read the detailed description
50 hundred children with traumatic brain injury from both sexes will participate in this study and fifty normal volunteer children for age matching group.
Materials:
- For selection: The Glasgow Coma Scale
- For evaluation: A. For Cognitive assessment: The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) B. Bruininks-Oseretsky Test of Motor Proficiency
C.Functional Independence Measure for Children:
Wee Functional Independence Measure (Wee FIM)
- Conditions
- Traumatic Brain Injury
- Keywords
- BALANCE, CHILDREN, COGNITIVE FUNCTION, FUNCTIONAL INDEPENDENCE, TRAUMATIC BRAIN INJURY
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A. 24 children with traumatic brain injury from both sexes will participate in this s | traumatic brain injury | |
| 24 normal volunteer children for age matching group. They will be selected from Zagazig universit | normal volunteer children for age matching group |
What is being measured
The primary outcome is the main question the study is designed to answer.
COGNITIVE FUNCTION
The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) assessment containing fifteen subtests
Measured: 60:120 minutes
balance
Bruininks-Oseretsky Test of Motor Proficiency is a commonly diagnostic instrument in the evaluation of the development of psychometrics . It is categorized into four composite motor domains each one containing two motor subtests
Measured: 15:25 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start14 Jul 2025
- Primary completion22 Feb 2026
- Study completionJul 2026 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan mohamed baiomy, Cairo University
- Investigators
- manal S.Eid abd elwahab, professor of physical therapy, Study chair, prof cairo universityAlaa F hassan, lecturer, Study director, lecturermustafa A EL Zohiery, lecturer, Study director, lecturer cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612410
- Sponsor's protocol ID
- 012/005949
- Acronym
- Impact TBI
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andelic, N., Løvstad, M., Norup, A., Ponsford, J., & Røe, C. (2019). Editorial: Impact of Traumatic Brain Injuries on Participation in Daily Life and Work: Recent Research and Future Directions. Front Neurol, 10, 1153. https://doi.org/10.3389/fneur.2019.01153 Barman, A., Chatterjee, A., & Bhide, R. (2016). Cognitive Impairment and Rehabilitation Strategies After Traumatic Brain Injury. Indian J Psychol Med, 38(3), 172-181. https://doi.org/10.4103/0253-7176.183086 Bidzan-Bluma, I., & Lipowska, M. (2018). Physical Activity and Cognitive Functioning of Children: A Systematic Review. Int J Environ Res Public Health, 15(4). https://doi.org/10.3390/ijerph15040800 Bland, D. C., Zampieri, C., & Damiano, D. L. (2011). Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Brain injury, 25(7-8), 664-679. Bronstein, A. M. (2016). Multisensory integration in balance control. Handb Clin Neurol, 137, 57-66. https://doi.org/10.1016/b978-0-444-63437-5.00004-2 Bruininks, P., & Malle, B. F. (2005). Distinguishing hope from optimism and related affective states. Motivation and emotion, 29, 324-352. Capizzi, A., Woo, J., & Verduzco-Gutierrez, M. (2020). Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am, 104(2), 213-238. https://doi.org/10.1016/j.mcna.2019.11.001 Chen, M., Dutt, A. S., & Nair, R. (2022). Systematic review of reviews on Activities of Daily Living measures for children with developmental disabilities. Heliyon, 8(6), e09698. https://doi.org/10.1016/j.heliyon.2022.e09698 Dewan, M. C., Rattani, A., Gupta, S., Baticulon, R. E., Hung, Y. C., Punchak, M., Agrawal, A., Adeleye, A. O., Shrime, M. G., Rubiano, A. M., Rosenfeld, J. V., & Park, K. B. (2018). Estimating the global incidence of traumatic brain injury. J Neurosurg, 130(4), 1080-1097. https://doi.org/10.3171/2017.10.Jns17352 Eriksen, B. A., & Eriksen, C. W. (1974). Effects of
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Traumatic Brain Injury on Cognitive Function, Balance and Functional Lndependence in Children
- ClinicalTrials.gov ID
- NCT07612410
- Acronym / sponsor ID
- Impact TBI / 012/005949
- Conditions
- Traumatic Brain Injury
- Keywords
- BALANCE, CHILDREN, COGNITIVE FUNCTION, FUNCTIONAL INDEPENDENCE, TRAUMATIC BRAIN INJURY
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 22 Feb 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 May 2026 (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 purpose of the study is to determine the impact of different levels of traumatic brain injury on cognitive function, functional independence and balance on children and relation of cognitive dysfunction, balance disturbance and functional independence
Detailed description
50 hundred children with traumatic brain injury from both sexes will participate in this study and fifty normal volunteer children for age matching group.
Materials:
- For selection: The Glasgow Coma Scale
- For evaluation: A. For Cognitive assessment: The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) B. Bruininks-Oseretsky Test of Motor Proficiency
C.Functional Independence Measure for Children:
Wee Functional Independence Measure (Wee FIM)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A. 24 children with traumatic brain injury from both sexes will participate in this s | – | –traumatic brain injury |
| 24 normal volunteer children for age matching group. They will be selected from Zagazig universit | – | –normal volunteer children for age matching group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 24 children with traumatic brain injury from both sexes will participate in this study and 24 normal volunteer children for age matching group.
Key inclusion criteria (3 listed)
- Children diagnosed with mild to moderate traumatic brain injury.
- Their chronological age will be ranged from 8 years to 12 years.
- All subjects medically controlled immediately after discharge.
Key exclusion criteria (6 listed)
- children with other neurological impairments or epilepsy.
- Visual or hearing impairment
- Motor or behavioral disorders before trauma such as Developmental Coordination Disorder (DCD) or Attention Deficit Hyperactive Disorder (ADHD).
- Receiving medical drugs that can cause confusion or make child less alert.
- any chronic diseases as cardiac or lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COGNITIVE FUNCTION
Time frame: 60:120 minutes
The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) assessment containing fifteen subtests
balance
Time frame: 15:25 minute
Bruininks-Oseretsky Test of Motor Proficiency is a commonly diagnostic instrument in the evaluation of the development of psychometrics . It is categorized into four composite motor domains each one containing two motor subtests
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- BackgroundAndelic, N., Løvstad, M., Norup, A., Ponsford, J., & Røe, C. (2019). Editorial: Impact of Traumatic Brain Injuries on Participation in Daily Life and Work: Recent Research and Future Directions. Front Neurol, 10, 1153. https://doi.org/10.3389/fneur.2019.01153 Barman, A., Chatterjee, A., & Bhide, R. (2016). Cognitive Impairment and Rehabilitation Strategies After Traumatic Brain Injury. Indian J Psychol Med, 38(3), 172-181. https://doi.org/10.4103/0253-7176.183086 Bidzan-Bluma, I., & Lipowska, M. (2018). Physical Activity and Cognitive Functioning of Children: A Systematic Review. Int J Environ Res Public Health, 15(4). https://doi.org/10.3390/ijerph15040800 Bland, D. C., Zampieri, C., & Damiano, D. L. (2011). Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Brain injury, 25(7-8), 664-679. Bronstein, A. M. (2016). Multisensory integration in balance control. Handb Clin Neurol, 137, 57-66. https://doi.org/10.1016/b978-0-444-63437-5.00004-2 Bruininks, P., & Malle, B. F. (2005). Distinguishing hope from optimism and related affective states. Motivation and emotion, 29, 324-352. Capizzi, A., Woo, J., & Verduzco-Gutierrez, M. (2020). Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am, 104(2), 213-238. https://doi.org/10.1016/j.mcna.2019.11.001 Chen, M., Dutt, A. S., & Nair, R. (2022). Systematic review of reviews on Activities of Daily Living measures for children with developmental disabilities. Heliyon, 8(6), e09698. https://doi.org/10.1016/j.heliyon.2022.e09698 Dewan, M. C., Rattani, A., Gupta, S., Baticulon, R. E., Hung, Y. C., Punchak, M., Agrawal, A., Adeleye, A. O., Shrime, M. G., Rubiano, A. M., Rosenfeld, J. V., & Park, K. B. (2018). Estimating the global incidence of traumatic brain injury. J Neurosurg, 130(4), 1080-1097. https://doi.org/10.3171/2017.10.Jns17352 Eriksen, B. A., & Eriksen, C. W. (1974). Effects of
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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.
manal S.Eid abd elwahab, professor of physical therapy study chair
prof cairo university
Alaa F hassan, lecturer study director
lecturer
mustafa A EL Zohiery, lecturer study director
lecturer cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COGNITIVE FUNCTION (time frame: 60:120 minutes). The study lists 2 primary outcomes in all. 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 NCT07612410, 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 28 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.