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

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: Not yet recruiting
• Conditions: Hemiparetic Cerebral Palsy
• Intervention / Treatment: Other: reciprocal electrical stimulation; Other: physical therapy program

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: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
balance change measured by humac balance system	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	change in social, psychological and physical domains	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Quality of life; Hemiparesis; Reciprocal electrical stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Paresis
• Other Study ID 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