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NCT Number: NCT06730763

Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children

The purpose of this study was to determine:

* If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children. * If there are any changes in risk of falling in CP spastic hemiplegic children or not.

Recruiting

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Giza Governorate, 3753450, Egypt

Location status: Recruiting

Location contact

Islam Hassan Fayed, Doctorate

CONTACT

[email protected]

00201097279742

About this study

With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range between 8-12 years old.
  • Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
  • the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
  • (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
  • Ability to understand and follow simple instructions.
  • Parent or guardian consent obtained

Exclusion criteria

  • Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
  • Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
  • Previous participation in a tDCS study within the past 6 months.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation (TDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain.

Other names: transcranial, TcDc

Exercise

Other

selected traditional physical therapy program for improve balance and decrease risk of falling

Other names: traditional

Primary outcomes

  1. The Fall Risk test

    Time frame: From enrollment to the end of treatment at 8 weeks

    The fall risk test allowed identification of potential fall candidates. Test results were compared to age dependent normative data. Scores higher than normative values suggested more fall risk index

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed fathy Awad, Master degree

CONTACT

[email protected]

00201061263992

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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