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Clinical Trials/NCT06730763
NCT06730763
Recruiting
Not Applicable

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

Cairo University1 site in 1 country30 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy (CP)
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
The Fall Risk test
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
June 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Ahmed Fathy Mahmoud Awd

Physiotherapist

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 Sites (1)

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