Functional Electrical Stimulation With Core Stabilization Exercises in Children With Spastic Diplegia

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy; Functional Electrical Stimulation; Core Stability

• Registration Number: NCT07110025
• Lead Sponsor: Cairo University

Brief Summary

This study was done to:

* investigate the combined effect of functional electrical stimulation with core stabilization exercises on pelvic tilting in children with spastic diplegia.

* To investigate the combined effect of functional electrical stimulation with core stabilization exercises on standing balance in children with spastic diplegia.

Detailed Description

Spastic diaplegia in children affects motor development and muscle tone. Functional electrical stimulation can improve range of motion, muscle strength, walking speed, and gait. Correcting pelvic position is crucial for treating postural weaknesses. Core stability programs are recommended for spastic cerebral palsy children. Rehabilitation programs should focus on restoring normal pelvic alignment to improve overall balance and functional abilities. This study investigates the effect of functional electrical stimulation on rectus abdominis and gluteus maximus muscles and core stabilization exercises in spastic diplegic cerebral palsy children.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Start: 2025-08-15
• Primary Completion: 2025-12-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Their age will range from 4 to 6 years.
• Their degree of spasticity will range from 1 to 1+, according to the modified Ashworth scale.
• Their motor function will be at level Ⅰ & Ⅱ according to gross motor function classification system.
• Their pelvic tilting angle will be more than 7.6°

Exclusion Criteria

• Musculoskeletal fixed deformities in lower limbs and spine
• Visual or hearing problems
• Epilepsy
• Botulinum toxin injection or orthopedic surgery within past 6 months or within study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of muscle tone	at baseline and after 12 weeks	The modified Ashworth scale will be used to determine the degree of spasticity of the affected lower limb; the child will be in supine position with head in neutral position, and the examiner will moves the knee of affected side through full range of flexion and extensions the child is instructed to stay relaxed and to avoid resisting or facilitating the joint movement applied by the examiner; children with grades 1 or 1+ will be included
Assessment of gross motor function level	at baseline and after 12 weeks	The Gross Motor Function Classification System is a clinical classification system with five levels based on functional limitations, the need for handheld mobility devices, and movement quality. It includes children with level I and II and those transported in a manual wheelchair.

Secondary Outcome Measures

Name	Time	Method
Assessment of change of pelvic tilting	at baseline and after 12 weeks	Pelvic inclinometers and pelvic meter (PALM) are devices designed to assess pelvic tilt. Pelvic inclinometers have adjustable arms for direct contact with bony landmarks, while Pelvic inclinometers and pelvic meter have adjustable arms for contact with the anterior superior iliac spine and posterior superior iliac spine. These devices are typically used in a relaxed standing position, with children with a pelvic tilting angle over 7.6° included.
Assessment of change of balance	at baseline and after 12 weeks	The Humac Balance System is a combination of a balance board and Humac Balance software, providing a robust assessment tool for static and dynamic balance. It offers various training and measurement routines, including weight-bearing random motions, center of pressure, limits of stability, and roadway measurements.

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, Cairo university; 🇪🇬 Cairo, Egypt