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

NCT ID: NCT07110025

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-01-15

Brief Summary

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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

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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.

Conditions

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Functional Electrical Stimulation Cerebral Palsy Core Stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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functional electrical stimulation and designed physiotherapy program

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

Group Type EXPERIMENTAL

designed physical therapy program

Intervention Type 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

Intervention Type 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.

designed physiotherapy program

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

Group Type ACTIVE_COMPARATOR

designed physical therapy program

Intervention Type 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.

Interventions

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designed physical therapy program

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.

Intervention Type OTHER

core stabilization exercise with neuromuscular electrical stimulation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelsamed Mahmoud Mohamed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Abdelsamed Mahmoud, physical therapist

Role: CONTACT

+201221646955

Facility Contacts

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Ahmed AbdElsamed Mahmoud, physical therapist

Role: primary

+201221646955

Other Identifiers

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Ahmed_Msc

Identifier Type: -

Identifier Source: org_study_id

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