Spastic HemiplegiaBMPB-HCPNCT07538297
Biomechanical Muscle Properties and Balance in Children With Spastic Hemiplegia
An observational study of Spastic Hemiplegia, run by South Valley University.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Hemiplegia
- What is being tested?
- hemiplegic group and normal group
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Spastic Hemiplegia
- Being tested
- hemiplegic group, normal group
- Keywords
- biomechanical Properties, balance, spastic hemiplegia
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemiplegic groupOther
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 groupOther
twenty normal children with no history of neurological or musculoskeletal disorders.
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic group | 20 children diagnosed with hemiplegic cerebral palsy Receives: Other: hemiplegic group | |
| normal group | 20 children of age-matched typically developing children with no history of neurological or musculoskeletal disorders Receives: Other: normal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to one day
center of pressure
HUMAC balance system will be used to assess center of pressure
Measured: up to one day
Secondary outcomes (5)
muscle dynamic stiffness
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.
Measured: up to one day
The modified clinical test of sensory integration of balance
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.
Measured: up to one day
muscle elasticity
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.
Measured: up to one day
mechanical stree relaxation time
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.
Measured: up to one day
muscle viscoelastic property
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).
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keroles Adel Ghoberial Shenouda, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538297
- Sponsor's protocol ID
- P.T.REC/012/006025
- Acronym
- BMPB-HCP
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Biomechanical Properties and Postural Control During Static and Dynamic Standing in Children With Spastic Hemiplegia
- ClinicalTrials.gov ID
- NCT07538297
- Acronym / sponsor ID
- BMPB-HCP / P.T.REC/012/006025
- Conditions
- Spastic Hemiplegia
- Keywords
- biomechanical Properties, balance, spastic hemiplegia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemiplegic group | – | Other: hemiplegic group20 children diagnosed with hemiplegic cerebral palsy |
| normal group | – | Other: normal group20 children of age-matched typically developing children with no history of neurological or musculoskeletal disorders |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemiplegic grouptwenty 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. | Other | hemiplegic group |
| normal grouptwenty normal children with no history of neurological or musculoskeletal disorders. | Other | normal group |
Primary outcome
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.
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.
center of pressure
Time frame: up to one day
HUMAC balance system will be used to assess center of pressure
5 secondary outcomes
muscle dynamic stiffness
Time frame: up to one day
The modified clinical test of sensory integration of balance
Time frame: up to one day
muscle elasticity
Time frame: up to one day
mechanical stree relaxation time
Time frame: up to one day
muscle viscoelastic property
Time frame: up to one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Hemiplegia, run by South Valley University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact keroles shenouda, master (01013494753, kerolesadel876@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oscillatory frequency (time frame: up to one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.