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

NCT07110025 | Not Yet Recruiting

• 1 other identifier: Ahmed_Msc
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Electrical Stimulation; Cerebral Palsy; Core Stability

Outcome Measures

Primary Outcomes (2)

• Assessment of muscle tone

  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

  at baseline and after 12 weeks

• Assessment of gross motor function level

  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.

  at baseline and after 12 weeks

Secondary Outcomes (2)

• Assessment of change of pelvic tilting

  at baseline and after 12 weeks

• Assessment of change of balance

  at baseline and after 12 weeks

Study Arms (2)

functional electrical stimulation and designed physiotherapy program

EXPERIMENTAL

Children in this group will receive the same training program as control group for 30-minutes in addition to functional electrical stimulation using EV-906 DIGITAL transcutaneous electrical nerve stimulation/EMS neuromuscular stimulator device during core stability exercises for 30-minutes 3 sessions/week for 3 months

Other: designed physical therapy program; Other: core stabilization exercise with neuromuscular electrical stimulation

designed physiotherapy program

ACTIVE COMPARATOR

Children in this group will receive designed physiotherapy program for 1 hour including core stability exercises focusing on correcting pelvic tilting and standing balance. Each child will participate for 1 hour, 3 sessions/week for 3 months

Other: designed physical therapy program

Interventions

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.

designed physiotherapy program; functional electrical stimulation and designed physiotherapy program

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.

functional electrical stimulation and designed physiotherapy program

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ahmed Abdelsamed Mahmoud, physical therapist

CONTACT

+201221646955; a.samed194@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: principal investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

EG (1)