- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538297
Biomechanical Muscle Properties and Balance in Children With Spastic Hemiplegia (BMPB-HCP)
Muscle Biomechanical Properties and Postural Control During Static and Dynamic Standing in Children With Spastic Hemiplegia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: keroles shenouda, master
- Phone Number: 01013494753
- Email: kerolesadel876@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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