Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP

May 14, 2026 updated by: Noura Farouk Hammad, Cairo University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Affections of musculoskeletal system including fixed contractures.
  • Visual , auditory , vestibular ,sensory disorders or cerebellar disease .
  • Botox injection in the last 6 months in gastrocnemius

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: a group of hemiparetic children their balance is disturbed

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
Other: reciprocal electrical stimulation
Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation
Other Names:
  • Everyway-EV906
Other: 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 Names:
  • designed physical therapy program
Sham Comparator: children diagnosed with hemiparetic CP

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: 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 Names:
  • designed physical therapy program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 monthes
quality of life change xby Egyptian quality of life questionnaire
Time Frame: 3 months
change in social, psychological and physical domains
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cairo2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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