Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07110025

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Functional Electrical Stimulation Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Core Stability Nervous System Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

out-patient clinic, faculty of physical therapy, Cairo university

Cairo, Egypt

Location contact

Ahmed AbdElsamed Mahmoud, physical therapist

CONTACT

[email protected]

+201221646955

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Designed physical therapy program

Other

a one-hour physical therapy program, focusing on abdominal and back muscle activation and improving balance during standing. The program includes exercises like supine on wedges, prone on wedges, weight shifting, and balance training.

core stabilization exercise with neuromuscular electrical stimulation

Other

The text describes various exercises for children to improve their physical abilities. These exercises include bridging, crab, plank, superhero, wheelbarrow walk, and kneeling on balls. The placement of electrodes on the gluteus maximus and rectus abdominis muscles is determined using anatomical landmarks. The electric current is generated using a biphasic symmetrical waveform with pulse width and intensity, and the stimulus frequency is adjusted to 35 Hz. The neuromuscular electric stimulation mode is used in a Synchronous mode.

Primary outcomes

  1. Assessment of muscle tone

    Time frame: 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

  2. Assessment of gross motor function level

    Time frame: 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 outcomes

  1. Assessment of change of pelvic tilting

    Time frame: 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.

  2. Assessment of change of balance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abdelsamed Mahmoud, physical therapist

CONTACT

[email protected]

+201221646955

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.