NCT07538297

Brief Summary

this study will be conducted to investigate the relationship between muscle tone and dynamic stiffness during balance control and postural stability in children with spastic hemiplegia

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 5, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

April 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 5, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

biomechanical Propertiesbalancespastic hemiplegia

Outcome Measures

Primary Outcomes (3)

  • oscillatory frequency

    The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess oscillation frequency. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher oscillation frequency indicates higher muscle tone, while increased stiffness reflects greater resistance to force application.

    up to one day

  • Limits of stability

    HUMAC balance system will be used to assess limits of stability.Limits of stability are known as the maximum distance a subject is able to move his/her COP in different directions while keeping the configuration of the BOS and while remaining stable.The test will be conducted at level 4, which represents the degree of distance to the farthest target. At this level, the task is considered relatively simple, as the distance between the center target and each surrounding target is minimal. Higher values obtained during the test indicate better performance.

    up to one day

  • center of pressure

    HUMAC balance system will be used to assess center of pressure

    up to one day

Secondary Outcomes (5)

  • muscle dynamic stiffness

    up to one day

  • The modified clinical test of sensory integration of balance

    up to one day

  • muscle elasticity

    up to one day

  • mechanical stree relaxation time

    up to one day

  • muscle viscoelastic property

    up to one day

Study Arms (2)

hemiplegic group

20 children diagnosed with hemiplegic cerebral palsy

Other: hemiplegic group

normal group

20 children of age-matched typically developing children with no history of neurological or musculoskeletal disorders

Other: normal group

Interventions

twenty children with mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale and Their motor function will be at level I and II according to Gross Motor Function Classification System.Their age will range from 6 to 12 years.

hemiplegic group

twenty normal children with no history of neurological or musculoskeletal disorders.

normal group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

forty children with their ages from 6 to 12 years old. Twenty children were hemiplegic with a mild degree of spasticity and level I, II motor function.other twenty children were normal

You may qualify if:

  • Their age will range from 6 to 12 years.
  • Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
  • Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
  • They will be able to follow instructions during evaluation procedures.
  • Their caregivers are of a good command of the English language.

You may not qualify if:

  • Botulinum toxin injections in the last 6 months.
  • The presence of visual or auditory impairments.
  • Surgical interference in upper, lower limbs and/or spine.
  • Muscloskeletal problems or fixed deformities in the spine and/or upper or/and lower extremities.
  • Seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

keroles shenouda, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 20, 2026

Study Start

April 17, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04