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

NCT06730763 | Recruiting DMC

• 1 other identifier: P.T.REC.012/005208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; spastic hemiplegia; risk of falling

Outcome Measures

Primary Outcomes (1)

• The Fall Risk test

  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

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Transcranial direct current stimulation; Other: Exercise

Group 2

ACTIVE COMPARATOR

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

Other: Exercise

Interventions

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.

Also known as: transcranial, TcDc

Group 1

Exercise OTHER

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

Also known as: traditional

Group 1; Group 2

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Giza Governorate, 3753450, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Interventions

Transcranial Direct Current Stimulation; Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ahmed fathy Awad, Master degree

CONTACT

00201061263992; ahmedawdpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

EG (1)