Diplegic Cerebral Palsy With SpasticityNCT06473181
The Impact Of Core Stability Exercises On Standing , Functional Balance And Gait In Diplegic Cerebral Palsy Children
A study testing Core stability exercises in people with Diplegic Cerebral Palsy With Spasticity, run by Kafrelsheikh University.
Trial summary
The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Diplegic Cerebral Palsy With Spasticity
- What is being tested?
- Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of diplegic CP made by paediatricians or pediatric neurologists
- children spasticity grades must range from 1 to 1+ according to MAS
- age must range from 4 to 10 years
- They Must be in level I or II on the Gross Motor Function Classifcation System (GMFCS)
Who cannot join
- A permanent deformity (bony or soft tissue contractures)
- visual or auditory defects
- Botox application to the lower extremity in the past 6 months or undergone a previous surgical intervention to ankle and knee
- history of epileptic seizure and any diagnosed cardiac or orthopaedic disability
Trial locations and contacts
No sites are listed yet.
Physiotherapist Nancy Mohamed Eid Metwaly shaban, Master contact
About this study
The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for movements of extremities in a coordinated manner. The aim of core stability training is to achieve the optimal physical ability tom the normal state of the spine in daily activities, in addition to developing the endurance and coordination of these core stability muscles.The Core stability may help to improve dynamic balance and muscle coordination between lower and upper extremities, as well as reducing injury risk and muscle imbalances . Core stability exercises have a positive effect on reducing pain, activating deep abdominal muscles, elevating the stability of lumbar spine and improving physical function in patients . The stability of the lumbo-pelvic region is crucial to provide a foundation for movement of the upper and lower extremities, to support loads, and to protect the spinal cord and nerve roots . The core muscles stabilize the spine and trunk during movements such as jumping, running, and throwing .
Read the detailed description
Cerebral palsy (CP) could be a cluster of disorders that have an effect on the event of movement and posture,inflicting activity limitation, and nonprogressive disturbances that occurred within the developing fetal or child brain.The main therapeutic goals for children with CP are the performance of functional activities and walking.
Children with CP have a limitation with activities due to the existing impairments in independent walking, climbing stairs, running, or walking over uneven surface .Functional limitation of children with CP may have various degrees due to loss of axial control with an imbalance of their movement .Balance has been defined as the elements of postural control that allow a child to safely perform everyday tasks . Poor balance control is one of the most contributing factors for poor gait and reaching movement because the maintenance of stability is critical to all movements . Children with CP have defects in postural mechanisms, including righting and equilibrium reactions, antigravity mechanism, proximal stability, and postural fixation . Diplegia is amongst the most widely recognized clinical subtypes of Cerebral Palsy (CP). It is used when the motor impairment is milder in the upper limbs than the lower limbs. Most children have major weakness in the trunk and hypertonic limbs .Diplegia is characterized by increased muscle tone with difficulty in relaxing. Active movements are slow and stiff with abnormal patterns. Lower limbs are more affected than upper limbs. Head and neck are unaffected but there is weakness and limited rotation of the trunk . Children with CP may experience a range of functional limitations as a result of loss of trunk control and movement imbalance. Balance is defined as the postural control elements which enable a child to safely execute daily tasks.Because maintaining stability is necessary for all movements, low balance control is one of the extreme common causes of unsafe walking or reaching function . So core stability training is preferred to maintain position and movement of body core. Stability training involves the abdomen muscles and pelvic and shoulder muscles, which maintain postural alignment and allow movements of extremities. Postural control is mainly for motion and depends on these muscles for stability and endurance. Components of core stability include strength, endurance, balance,nd the related activity of the back, abdominal, and pelvic muscles . The core muscles act like one block to keep the body stable during static state and with extremity motion . CP children lack the ability to distribute the load, that is, body weight, appropriately during static balance and transfer the body weight adequately from one supporting limb to another during dynamic balance tasks . Children with diplegic CP are characterized by impairment of motor control in the lower extremities more than in the upper extremities.
Statement of the problem This study will be conducted to answer the following research question:Is there any significant effect of core stability exercises on standing , balance and gait in Diplegic cerebral palsy children ? Purpose of the study The purpose of this study is to study the effect of core stability training on standing, balance and gait in spastic diplegic cerebral palsy children.
Significance of the study Spasticity, muscle contraction, bony malformations, loss of selective motor control, and muscle weakness are potential factors that interfere with normal gait patterns in diplegic CP. Recent studies have found that muscle weakness limits motor function in children with CP more than spasticity. Therefore, strengthening weak muscles is es-sential for spasticity management to improve the func-tion of diplegic CP.Balance disorder is a serious problem for children with diplegic CP, and this can make it difficult to achieve and maintain equilibrium. Children with diplegic CP have reduced neuromotor perceptual func-tion, inadequate stance stability in different sensory settings, slow anticipatory response, and inaccurate pre-paratory activation.
The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for movements of extremities in a coordinated manner. Spinal stability is essential for the production of movement and relies on the core muscles to acquire sufficient strength, power, and endurance .The core has illustrated by researchers as a "power-house" for initiating limb movement or as a double-walled cylinder or box in which the abdominals act as the front of the house, the paraspinals serve as the back, the diaphragm serves as the roof, and the musculature of the hip girdle and pelvic floor create the 2 basement of the house.
- Conditions
- Diplegic Cerebral Palsy With Spasticity
- Being tested
- Core stability exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability exercisesOther
Exercises applied to trunk , pelvis and abdomen to improve ability to stand , walk and balance.
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercises that is part of physiotherapy rehabilitation | Other | Physical therapy including core stability exercises and improving developmental milestones to improve children development Receives: Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric balance scale
To assess the static balance Pediatric Balance Scale scores are divided into 14 items, scored between 0 to 4. What counts as 0 and 4 will vary from exercise to exercise, but 0 is considered the worst performance, and 4 is the best.
Retrials are unnecessary if they score a 4 on the first trial. Since each exercise has three trials, the score rating you must tick for each item should be the best of the three trials.
Some exercises have time and distance requirements. Points will be deducted if they cannot complete the time and distance requirements and require external support or assistance from another person.
After all the exercises have been performed, you simply need to add up all the score ratings per item to calculate the total test score.
The maximum score is 56.
Measured: Baseline
Gross motor function classification system
To assess the gross motor function and standing The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate
- = initiates
- = partially completes
- = completes
Measured: Baseline
Modified Ashworth scale
To measure the degree of spasticity to enroll children in the study
scoring
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )
2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
3 considerable increase in tone, passive movement difficult
4 limb rigid in flexion or extension
Measured: Baseline
Weight-Height scale
To measure weight and height to calculate BMI for each patient . The child was wearing a thin layer of clothes to calculate BMI according to the following equation: BMI (Kg/m²)= weight(kg) ÷ height²(m2)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral Palsy With SpasticityStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nancy mohamed eid metwaly shaban, Kafrelsheikh University
- Investigators
- Core stability training In Diplegic Cerebral Palsy, Master, Principal investigator, Kafr Elsheikh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473181
- Sponsor's protocol ID
- KFSIRB200-162
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Core Stability Exercises On Standing , Functional Balance And Gait In Diplegic Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT06473181
- Acronym / sponsor ID
- KFSIRB200-162
- Conditions
- Diplegic Cerebral Palsy With Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 25 Jun 2024 (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.
The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for movements of extremities in a coordinated manner. The aim of core stability training is to achieve the optimal physical ability tom the normal state of the spine in daily activities, in addition to developing the endurance and coordination of these core stability muscles.The Core stability may help to improve dynamic balance and muscle coordination between lower and upper extremities, as well as reducing injury risk and muscle imbalances . Core stability exercises have a positive effect on reducing pain, activating deep abdominal muscles, elevating the stability of lumbar spine and improving physical function in patients . The stability of the lumbo-pelvic region is crucial to provide a foundation for movement of the upper and lower extremities, to support loads, and to protect the spinal cord and nerve roots . The core muscles stabilize the spine and trunk during movements such as jumping, running, and throwing .
Detailed description
Cerebral palsy (CP) could be a cluster of disorders that have an effect on the event of movement and posture,inflicting activity limitation, and nonprogressive disturbances that occurred within the developing fetal or child brain.The main therapeutic goals for children with CP are the performance of functional activities and walking.
Children with CP have a limitation with activities due to the existing impairments in independent walking, climbing stairs, running, or walking over uneven surface .Functional limitation of children with CP may have various degrees due to loss of axial control with an imbalance of their movement .Balance has been defined as the elements of postural control that allow a child to safely perform everyday tasks . Poor balance control is one of the most contributing factors for poor gait and reaching movement because the maintenance of stability is critical to all movements . Children with CP have defects in postural mechanisms, including righting and equilibrium reactions, antigravity mechanism, proximal stability, and postural fixation . Diplegia is amongst the most widely recognized clinical subtypes of Cerebral Palsy (CP). It is used when the motor impairment is milder in the upper limbs than the lower limbs. Most children have major weakness in the trunk and hypertonic limbs .Diplegia is characterized by increased muscle tone with difficulty in relaxing. Active movements are slow and stiff with abnormal patterns. Lower limbs are more affected than upper limbs. Head and neck are unaffected but there is weakness and limited rotation of the trunk . Children with CP may experience a range of functional limitations as a result of loss of trunk control and movement imbalance. Balance is defined as the postural control elements which enable a child to safely execute daily tasks.Because maintaining stability is necessary for all movements, low balance control is one of the extreme common causes of unsafe walking or reaching function . So core stability training is preferred to maintain position and movement of body core. Stability training involves the abdomen muscles and pelvic and shoulder muscles, which maintain postural alignment and allow movements of extremities. Postural control is mainly for motion and depends on these muscles for stability and endurance. Components of core stability include strength, endurance, balance,nd the related activity of the back, abdominal, and pelvic muscles . The core muscles act like one block to keep the body stable during static state and with extremity motion . CP children lack the ability to distribute the load, that is, body weight, appropriately during static balance and transfer the body weight adequately from one supporting limb to another during dynamic balance tasks . Children with diplegic CP are characterized by impairment of motor control in the lower extremities more than in the upper extremities.
Statement of the problem This study will be conducted to answer the following research question:Is there any significant effect of core stability exercises on standing , balance and gait in Diplegic cerebral palsy children ? Purpose of the study The purpose of this study is to study the effect of core stability training on standing, balance and gait in spastic diplegic cerebral palsy children.
Significance of the study Spasticity, muscle contraction, bony malformations, loss of selective motor control, and muscle weakness are potential factors that interfere with normal gait patterns in diplegic CP. Recent studies have found that muscle weakness limits motor function in children with CP more than spasticity. Therefore, strengthening weak muscles is es-sential for spasticity management to improve the func-tion of diplegic CP.Balance disorder is a serious problem for children with diplegic CP, and this can make it difficult to achieve and maintain equilibrium. Children with diplegic CP have reduced neuromotor perceptual func-tion, inadequate stance stability in different sensory settings, slow anticipatory response, and inaccurate pre-paratory activation.
The term of "core stability" explains the capacity to control the position and movement of the central portion of the body. Core stability training targets the muscles deep within the abdomen that attach to the spine, pelvis and shoulders, that help in the preservation of proper posture and provide the basis for movements of extremities in a coordinated manner. Spinal stability is essential for the production of movement and relies on the core muscles to acquire sufficient strength, power, and endurance .The core has illustrated by researchers as a "power-house" for initiating limb movement or as a double-walled cylinder or box in which the abdominals act as the front of the house, the paraspinals serve as the back, the diaphragm serves as the roof, and the musculature of the hip girdle and pelvic floor create the 2 basement of the house.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Core stability exercises that is part of physiotherapy rehabilitation | Other | Other: Core stability exercisesPhysical therapy including core stability exercises and improving developmental milestones to improve children development |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A clinical diagnosis of diplegic CP made by paediatricians or pediatric neurologists
- children spasticity grades must range from 1 to 1+ according to MAS
- age must range from 4 to 10 years
- They Must be in level I or II on the Gross Motor Function Classifcation System (GMFCS)
Key exclusion criteria (4 listed)
- A permanent deformity (bony or soft tissue contractures)
- visual or auditory defects
- Botox application to the lower extremity in the past 6 months or undergone a previous surgical intervention to ankle and knee
- history of epileptic seizure and any diagnosed cardiac or orthopaedic disability
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 |
|---|---|---|
| Core stability exercisesExercises applied to trunk , pelvis and abdomen to improve ability to stand , walk and balance. | Other | Core stability exercises that is part of physiotherapy rehabilitation |
Primary outcome
Pediatric balance scale
Time frame: Baseline
To assess the static balance Pediatric Balance Scale scores are divided into 14 items, scored between 0 to 4. What counts as 0 and 4 will vary from exercise to exercise, but 0 is considered the worst performance, and 4 is the best. Retrials are unnecessary if they score a 4 on the first trial. Since each exercise has three trials, the score rating you must tick for each item should be the best of the three trials. Some exercises have time and distance requirements. Points will be deducted if they cannot complete the time and distance requirements and require external support or assistance from another person. After all the exercises have been performed, you simply need to add up all the score ratings per item to calculate the total test score. The maximum score is 56.
Gross motor function classification system
Time frame: Baseline
To assess the gross motor function and standing The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes
Modified Ashworth scale
Time frame: Baseline
To measure the degree of spasticity to enroll children in the study scoring 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
Weight-Height scale
Time frame: Baseline
To measure weight and height to calculate BMI for each patient . The child was wearing a thin layer of clothes to calculate BMI according to the following equation: BMI (Kg/m²)= weight(kg) ÷ height²(m2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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. This study is not recruiting at the moment.
Physiotherapist Nancy Mohamed Eid Metwaly shaban, Master contact
Core stability training In Diplegic Cerebral Palsy, Master principal investigator
Kafr Elsheikh
Questions about this trial
What is this clinical trial studying?
A study testing Core stability exercises in people with Diplegic Cerebral Palsy With Spasticity, run by Kafrelsheikh 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Physiotherapist Nancy Mohamed Eid Metwaly shaban, Master (050-2640850 ext. +2010 1327670, nancymohamed054@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric balance scale (time frame: Baseline). The study lists 4 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 25 Jun 2024.