Hemiparetic Cerebral PalsyNCT07599267
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
A study testing reciprocal electrical stimulation and physical therapy program in people with Hemiparetic Cerebral Palsy, run by Cairo University.
Trial summary
to investigate the effect of the reciprocal neuromuscular electrical stimulation on balance and quality of life in hemiparetic children Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy
- What is being tested?
- reciprocal electrical stimulation and physical therapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 15 Sep 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age range from 6 to10 years .
- spasticity level 1 , 1+ in lower limb muscles according to Modified Ashworth Scale.
- Gross Motor Function Classification System (GMFCS) level 1.
- Able to follow instructions.
Who cannot join
- Affections of musculoskeletal system including fixed contractures.
- Visual , auditory , vestibular ,sensory disorders or cerebellar disease .
- Botox injection in the last 6 months in gastrocnemius
About this study
Official title: Effect of Reciprocal Neuromuscular Electrical Stimulation on Balance and Quality of Life in Children With Hemiparesis
to investigate the effect of the reciprocal neuromuscular electrical stimulation on balance and quality of life in hemiparetic children
Read the detailed description
Neuromuscular Electrical Stimulation is widely used to reduce spasticity and strengthen weak muscles.
Reciprocal electrical stimulation ( RES),which mimic natural agonist-antagonist muscle activation , is a promising too for neuromuscular re-education.
RES has been studied for knee stability in diplegic CP and ankle control in adults but its effect on static and dynamic balance in hemiparetic CP remain unexplored . so this study may be a guide in management of balance problems in children with hemiparesis
- Conditions
- Hemiparetic Cerebral Palsy
- Being tested
- reciprocal electrical stimulation, physical therapy program
- Keywords
- Reciprocal electrical stimulation, Hemiparesis, Balance, Quality of life
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reciprocal electrical stimulationOther
Also called Everyway-EV906
Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation
physical therapy programOther
Also called designed physical therapy program
- neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
- training for active trunk extension to improve posture control and balance .
- Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board.
- facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance.
- approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and stimulate the joint mechanoreceptors from semi reclined and quadruped positions.
| Study group | Role | What they receive |
|---|---|---|
| a group of hemiparetic children their balance is disturbed | Experimental | children diagnosed with hemiparetic CP will receive reciprocal electrical stimulation in combination with neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
* training for active trunk extension to improve posture control and balance .
* Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board.
* facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance.
* approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and Receives: Other: reciprocal electrical stimulation; Other: physical therapy program |
| children diagnosed with hemiparetic CP | Sham comparator | neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control.
* training for active trunk extension to improve posture control and balance .
* Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board.
* facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance.
* approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and stimulate the joint mechanoreceptors from semi reclined and quadruped positions. Receives: Other: physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance change measured by humac balance system
the ability to maintain a stable posture and preserve it in counter gravity position
Measured: 3 monthes
quality of life change xby Egyptian quality of life questionnaire
change in social, psychological and physical domains
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start20 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic Cerebral PalsyStudies 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
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Farouk Hammad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599267
- Sponsor's protocol ID
- cairo2025
- Status last verified
- May 2026
- First submitted
- 3 Dec 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reciprocal Neuromuscular Electrical Stimulation on Balance and Quality of Life in Children With Hemiparesis
- ClinicalTrials.gov ID
- NCT07599267
- Acronym / sponsor ID
- cairo2025
- Conditions
- Hemiparetic Cerebral Palsy
- Keywords
- Reciprocal electrical stimulation, Hemiparesis, Balance, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 20 May 2026 (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.
to investigate the effect of the reciprocal neuromuscular electrical stimulation on balance and quality of life in hemiparetic children
Detailed description
Neuromuscular Electrical Stimulation is widely used to reduce spasticity and strengthen weak muscles.
Reciprocal electrical stimulation ( RES),which mimic natural agonist-antagonist muscle activation , is a promising too for neuromuscular re-education.
RES has been studied for knee stability in diplegic CP and ankle control in adults but its effect on static and dynamic balance in hemiparetic CP remain unexplored . so this study may be a guide in management of balance problems in children with hemiparesis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a group of hemiparetic children their balance is disturbed | Experimental | Other: reciprocal electrical stimulation, Other: physical therapy programchildren diagnosed with hemiparetic CP will receive reciprocal electrical stimulation in combination with neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control. * training for active trunk extension to improve posture control and balance . * Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board. * facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance. * approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and |
| children diagnosed with hemiparetic CP | Sham comparator | Other: physical therapy programneurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control. * training for active trunk extension to improve posture control and balance . * Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board. * facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance. * approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and stimulate the joint mechanoreceptors from semi reclined and quadruped positions. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age range from 6 to10 years .
- spasticity level 1 , 1+ in lower limb muscles according to Modified Ashworth Scale.
- Gross Motor Function Classification System (GMFCS) level 1.
- Able to follow instructions.
Key exclusion criteria (3 listed)
- Affections of musculoskeletal system including fixed contractures.
- Visual , auditory , vestibular ,sensory disorders or cerebellar disease .
- Botox injection in the last 6 months in gastrocnemius
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 |
|---|---|---|
| reciprocal electrical stimulationAlso: Everyway-EV906Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation | Other | a group of hemiparetic children their balance is disturbed |
| physical therapy programAlso: designed physical therapy program* neurodevelopmental approach directed toward inhibiting abnormal muscle tone and abnormal reflexes and facilitation of postural control through reflex inhibiting positions using proximal and distal key points of control. * training for active trunk extension to improve posture control and balance . * Balance training from different positions ,from the quadruped position, kneeling ,half kneeling and standing position on mat and tilting board. * facilitation of protective reactions by applying a fast and large amplitude of stimulus to train saving reactions from sitting on roll and also from standing position by pushing the child to encourage the child to take protective steps either forward , backward .or sideways to regain balance. * approximation as a proprioceptive training applied in a slow and rhythmic manner for the upper limbs ,lower limbs , and trunk to control spasticity and stimulate the joint mechanoreceptors from semi reclined and quadruped positions. | Other | a group of hemiparetic children their balance is disturbed, children diagnosed with hemiparetic CP |
Primary outcome
balance change measured by humac balance system
Time frame: 3 monthes
the ability to maintain a stable posture and preserve it in counter gravity position
quality of life change xby Egyptian quality of life questionnaire
Time frame: 3 months
change in social, psychological and physical domains
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 20 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hemiparetic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing reciprocal electrical stimulation and physical therapy program in people with Hemiparetic Cerebral Palsy, run by Cairo University.
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 3 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance change measured by humac balance system (time frame: 3 monthes). 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 20 May 2026.