Functional Electrical StimulationNCT07110025
Functional Electrical Stimulation With Core Stabilization Exercises in Children With Spastic Diplegia
A study testing designed physical therapy program and core stabilization exercise with neuromuscular electrical stimulation in people with Functional Electrical Stimulation and Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Functional Electrical Stimulation, Cerebral Palsy, Core Stability
- What is being tested?
- designed physical therapy program and core stabilization exercise with neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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°
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Cairo
Ahmed AbdElsamed Mahmoud, physical therapist, +201221646955, a.samed194@gmail.com
About this study
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.
Read the 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.
- Being tested
- designed physical therapy program, core stabilization exercise with neuromuscular electrical stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
designed physical therapy programOther
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 stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: at baseline and after 12 weeks
Secondary outcomes (2)
Assessment of change of pelvic tilting
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.
Measured: at baseline and after 12 weeks
Assessment of change of balance
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.
Measured: at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Electrical StimulationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsamed Mahmoud Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110025
- Sponsor's protocol ID
- Ahmed_Msc
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation With Core Stabilization Exercises in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT07110025
- Acronym / sponsor ID
- Ahmed_Msc
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional electrical stimulation and designed physiotherapy program | Experimental | Other: designed physical therapy program, Other: core stabilization exercise with neuromuscular electrical stimulationChildren 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 |
| designed physiotherapy program | Active comparator | Other: designed physical therapy programChildren 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 |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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°
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| designed physical therapy programa 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. | Other | designed physiotherapy program, functional electrical stimulation and designed physiotherapy program |
| core stabilization exercise with neuromuscular electrical stimulationThe 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. | Other | functional electrical stimulation and designed physiotherapy program |
Primary outcome
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
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.
2 secondary outcomes
Assessment of change of pelvic tilting
Time frame: at baseline and after 12 weeks
Assessment of change of balance
Time frame: at baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Related trials for Functional Electrical Stimulation
Not yet recruiting
Functional Electrical Stimulation Plus High Intensity Interval Training at Home
Spinal Cord Injuries (SCI)
Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
Recruiting
Functional Electrical Stimulation Combined With Exercise for Rotator Cuff-Related Shoulder Pain in Older Adults
Rotator Cuff Disease, Subacromial Pain Syndrome
Recruiting
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Stroke
Recruiting
Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
Spinal Cord Injury, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing designed physical therapy program and core stabilization exercise with neuromuscular electrical stimulation in people with Functional Electrical Stimulation and Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelsamed Mahmoud, physical therapist (+201221646955, a.samed194@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of muscle tone (time frame: at baseline and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.