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

NCT ID: NCT06730763

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-06-01

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.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

will receive selected traditional physical therapy program for improve balance and decrease risk of falling only.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: 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.

Exercise

Intervention Type: OTHER

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

Group 2

will receive transcranial direct current stimulation plus selected traditional physical therapy program.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Interventions

Transcranial direct current stimulation

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.

Intervention Type: DEVICE

Exercise

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

Intervention Type: OTHER

Other Intervention Names

transcranial; TcDc; traditional

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ahmed Fathy Mahmoud Awd

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed fathy Awad, Master degree

Role: CONTACT

ahmedawdpt@gmail.com

00201061263992

Facility Contacts

Islam Hassan Fayed, Doctorate

Role: primary

islamfayed@outlook.com

00201097279742

Other Identifiers

P.T.REC.012/005208

Identifier Type: -

Identifier Source: org_study_id