NCT07599267

Brief Summary

to investigate the effect of the reciprocal neuromuscular electrical stimulation on balance and quality of life in hemiparetic children

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Sep 2026

First Submitted

Initial submission to the registry

December 3, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

December 3, 2025

Last Update Submit

May 14, 2026

Conditions

Keywords

Reciprocal electrical stimulationHemiparesisBalanceQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Other: reciprocal electrical stimulationOther: 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.

Other: physical therapy program

Interventions

Mode (A) is selected to apply reciprocal neuromuscular electrical stimulation

Also known as: Everyway-EV906
a group of hemiparetic children their balance is disturbed

* 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.

Also known as: designed physical therapy program
a group of hemiparetic children their balance is disturbedchildren diagnosed with hemiparetic CP

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

December 3, 2025

First Posted

May 20, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share