NCT07612410

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 18, 2026

Last Update Submit

May 23, 2026

Conditions

Keywords

BALANCECHILDRENCOGNITIVE FUNCTIONFUNCTIONAL INDEPENDENCETRAUMATIC BRAIN INJURY

Outcome Measures

Primary Outcomes (2)

  • COGNITIVE FUNCTION

    The Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV) assessment containing fifteen subtests

    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

    15:25 minute

Study Arms (2)

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

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • manal S.Eid abd elwahab, professor of physical therapy

    prof cairo university

    STUDY CHAIR
  • Alaa F hassan, lecturer

    lecturer

    STUDY DIRECTOR
  • mustafa A EL Zohiery, lecturer

    lecturer cairo university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 28, 2026

Study Start

July 14, 2025

Primary Completion

February 22, 2026

Study Completion

July 1, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations