Biomechanical Muscle Properties and Balance in Children With Spastic Hemiplegia (BMPB-HCP)

April 12, 2026 updated by: Keroles Adel Ghoberial Shenouda, South Valley University

Muscle Biomechanical Properties and Postural Control During Static and Dynamic Standing in Children With Spastic Hemiplegia

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Cerebral palsy (CP) is a neurodevelopmental disorder that affects muscle tone, posture and motor skills. It is the most common cause of motor disability in infants and children. It describes a group of permanent disorders resulting from non-progressive injury to the fetal or infant developing brain. Although the disorder itself is non-progressive, the clinical manifestations change over time as the brain matures.Children with hemiplegic CP often have difficulty performing voluntary movements due to decreased muscle strength and abnormal muscle tone. As a result, the child are unable to generate the necessary force to maintain their positions against gravity, leading to abnormal posture and balance. Myotonometers are compact, noninvasive tools that swiftly and efficiently gauge the biomechanical characteristics of soft tissues. In typically developing (TD) children, in children with developmental disabilities, and in individuals affected by stroke, it was found to be reliable.Balance is the capacity to preserve equilibrium against gravity during upright postures by maintaining the COM over the center of the BOS. It involves reacting to internal (voluntary movements) and external disturbing forces rapidly and effectively through different postural mechanisms to recover stability. It can be classified into static (maintaining the BOS with minimum movements), and dynamic (maintaining the BOS during different body movements). A comprehensive examination of muscle tone in UCP children can help us understand its impact on motor function and develop more targeted therapeutic interventions.

This understanding can have important clinical implications for treatment efficacy, rehabilitation strategies, and neurophysiological assessments. Addressing muscle tone abnormalities provides a more complete picture of the motor impairments and guides the development of individualized treatment plans, ultimately improving functional outcomes for children with UCP. Therefore, this study aimed to investigate the biomechanical properties, such as muscle tone and stiffness in the lower limb muscles of children with UCP compared with their TD peers. Additionally, investigators explored the associations between these properties and balance control in children with hemiplegia.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hemiplegic group
20 children diagnosed with hemiplegic cerebral palsy
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.
normal group
20 children of age-matched typically developing children with no history of neurological or musculoskeletal disorders
twenty normal children with no history of neurological or musculoskeletal disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oscillatory frequency
Time Frame: up to one day
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
Time Frame: up to one day
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
Time Frame: up to one day
HUMAC balance system will be used to assess center of pressure
up to one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle dynamic stiffness
Time Frame: up to one day
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle dynamic stiffness. 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 dynamic stiffness indicates greater resistance to force application.
up to one day
The modified clinical test of sensory integration of balance
Time Frame: up to one day
HUMAC balance system will be used to assess sensory integration of balance or stability score.This test begins with the participant standing on the HUMAC board with the middle of his/her feet lined up with the 7's on the horizontal axis, and the medial malleolus lined up with a letter along the vertical axis. The child will be instructed to stand in a neutral position with his/her arms beside the body for thirty seconds. As participants completed the test, the board monitored their COP to determine their stability score and path length. the score determined patient stability. A higher score indicates more stability, and a lower score indicates lower stability.
up to one day
muscle elasticity
Time Frame: up to one day
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle elasticity. it quantifies the dissipation of mechanical energy (damping) during natural oscillations of a muscle. lower values signify higher elasticity (i.e., better ability to recover from deformation), while higher values suggest lower elasticity.
up to one day
mechanical stree relaxation time
Time Frame: up to one day
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess mechanical stree relaxation time with ms.It represents the duration of the muscle recovery process (or the relaxation time) from displacement.the higher tissue tension or stiffness, the faster tissue recovers its shape, meaning the lower the value.
up to one day
muscle viscoelastic property
Time Frame: up to one day
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to viscoelastic properity. It represents the relationship between the time it takes for a tissue to undergo creep (gradual elongation) and the time it takes for it to recover or relax after being under constant deformation.Lower values: Indicate higher tissue tension, structural integrity, or increased stiffness (faster recovery).Higher values: Indicate greater viscoelasticity (slower recovery, more creep).
up to one day

Collaborators and Investigators

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

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)

April 17, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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