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NCT Number: NCT07538297

Biomechanical Muscle Properties and Balance 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hemiplegic group

Other

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

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. center of pressure

    Time frame: up to one day

    HUMAC balance system will be used to assess center of pressure

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

keroles shenouda, master

CONTACT

[email protected]

01013494753

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Acronym: BMPB-HCP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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