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

Not Applicable

Recruiting

• Conditions: Cerebral Palsy (CP)

• Registration Number: NCT06730763
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Fall Risk test	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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt