- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07612410
Impact of Traumatic Brain Injury on Cognitive Function, Balance and Functional Independence in Children (Impact TBI)
May 23, 2026 updated by: Nourhan mohamed baiomy, Cairo University
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
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 02
- Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group A. 24 children with traumatic brain injury from both sexes will participate in this s
traumatic brain injury
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24 normal volunteer children for age matching group. They will be selected from Zagazig universit
normal volunteer children for age matching group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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COGNITIVE FUNCTION
Time Frame: 60:120 minutes
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The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) assessment containing fifteen subtests
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60:120 minutes
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balance
Time Frame: 15:25 minute
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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
|
15:25 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: manal S.Eid abd elwahab, professor of physical therapy, prof cairo university
- Study Director: Alaa F hassan, lecturer, Lecturer
- Study Director: mustafa A EL Zohiery, lecturer, lecturer cairo university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2025
Primary Completion (Actual)
February 22, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
May 18, 2026
First Submitted That Met QC Criteria
May 23, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 23, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/005949
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.