Cerebral PalsyNCT06180395
Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy
An observational study of Cerebral Palsy and Bone Density, Low, run by Cairo University at 1 site in Egypt.
Trial summary
studying the relationship between Bone Mineral Density, Gross Motor Function and, Quality of Life with CP can provide valuable insights into the musculoskeletal consequences of motor impairments and guide interventions to improve bone health. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Cerebral Palsy, Bone Density, Low, Gross Motor Development Delay
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to Apr 2024
- Phase
- Observational
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Seventy- five CP Children will be divided into two groups according to GMFCS: 1. Group 1 (Ambulant ) consisted of 35 children with CP classified to level I, II and III according to GMFCS. 2. Group 2 (Non-Ambulant ) consisted of 35 children with CP classified to level IV and V according to GMFCS. All measured variables will be identified for children of both groups, then correlation between BMD, gross motor function and QoL will be determined.
Who may be able to join
- Children with CP (spastic diplegia and quadriplegia).
- Their chronological ages will be ranged from 7 to 10 years.
- They will be selected from both genders.
- Their motor function will be at any Level according to GMFCS.
- Their body mass index (BMI ) will be normal.
Who cannot join
- Children will be excluded from the study if they have any of the following :
- Underweight, Overweight or Obese.
- Epilepsy , kidney problems that make them taking hormonal treatments or drugs affect bone density or taking calcium, vitamin D, steroids during 6 months prior to the study.
- Fracture in the measurement areas.
- Hip Flexion deformity more than 30° when posed to measure.
- Internal metallic fixations in the measurement areas (neck of femur and lumber vertebra from L1-L4).
- Hyperthyroidism or Hypothyroidism.
- Hypotonia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine , Cairo University
Giza
shimaa Emara, M.Sc
About this study
studying the relationship between Bone Mineral Density, Gross Motor Function and, Quality of Life with CP can provide valuable insights into the musculoskeletal consequences of motor impairments and guide interventions to improve bone health.
Statement of the problem Is there a relation between Bone Mineral Density, Gross Motor Function and Quality of Life in children with CP ? Purpose of the study
To study the relationship between:
- Bone Mineral Density and Gross Motor Function in ambulant and non-ambulant CP children.
- Bone Mineral Density and Quality of Life in ambulant and non-ambulant CP children.
- Gross Motor Function and Quality of Life in ambulant and non-ambulant CP children.
Read the detailed description
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuro pathologic lesion is non-progressive, children with cerebral palsy may develop a range of secondary conditions over time that will variably affect their functional abilities. The prevalence of CP varies between 1.5 to more than 4 cases per 1,000 live births worldwide. The motor impairments associated with CP can range from mild to severe, affecting different muscle groups and leading to difficulties in activities of daily living and participation in social and recreational activities.
Children with CP often experience motor impairments that affect their gross motor function, leading to limitations in activities and participation. These motor impairments can also have a negative impact on bone health, resulting in reduced bone mineral density (BMD) and increased risk of skeletal complications.
Gross motor function (GMF) refers to the ability to perform coordinated movements using large muscle groups, such as walking, running, and jumping. It is a key aspect of physical ability and independence in daily activities for children with CP. Previous research has shown that gross motor function is closely associated with bone health in this population. However, further investigation is needed to explore the specific nature of this correlation and its implications for intervention strategies.
Gross motor function is commonly assessed using standardized tools such as the Gross Motor Function Classification System (GMFCS) or the Gross Motor Function Measure (GMFM). Quality of life is a multidimensional construct that encompasses physical, psychological, and social well-being. In the context of cerebral palsy, understanding the impact of gross motor function on quality of life is crucial for comprehensive care and intervention planning. Children with CP may face limitations in mobility, participation in activities, and social interactions, which can significantly affect their overall quality of life. Exploring the relationship between gross motor function and quality of life can provide valuable insights into the factors influencing the holistic well-being of children with CP.
The quality of life in children with CP is not only influenced by their motor function but also by their overall health and well-being. Bone health plays a crucial role in maintaining the physical abilities and independence of individuals, as well as their overall quality of life. Impaired bone health in children with CP can lead to limitations in mobility, increased pain, and reduced participation in activities, which can have a significant impact on their overall well-being.
Bone mineral density, on the other hand, is an important measure of bone strength and overall skeletal health. Children with CP often exhibit lower BMD compared to typically developing peers due to factors such as reduced weight-bearing activities, muscle weakness, altered biomechanics, limited mobility, and hormonal imbalances. This reduced BMD increases their susceptibility to fractures and skeletal deformities, further impacting their functional abilities and quality of life.
- Being tested
- Group 1, Group 2
- Medical subject headings
- Cerebral Palsy, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
Also called Ambulant
consisted of 37 children with CP classified to level I, II and III according to GMFCS., then:
Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).
Group 2Other
Also called Non-Ambulant
consisted of 38 children with CP classified to level IV and V according to GMFCS. then:
Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Ambulant ) | consisted of 37 children with CP classified to level I, II and III according to GMFCS., then:
1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). Receives: Other: Group 1 | |
| Group 2 (Non-Ambulant ) | consisted of 38 children with CP classified to level IV and V according to GMFCS.then:
1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). Receives: Other: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-energy X-ray absorptiometry (DXA) scans
Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
Measured: 1 day
Gross motor function measurement scale (GMFM)
Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
Measured: 1 day
Quality of Life Questionnaire for Children (CP QOL-Child)
Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start10 Jan 2024
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Talaat Elsayed Emara, Cairo University
- Investigators
- Elham Elsayed Salem, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180395
- Sponsor's protocol ID
- CairoU_STE
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06180395
- Acronym / sponsor ID
- CairoU_STE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 22 Dec 2023 (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.
studying the relationship between Bone Mineral Density, Gross Motor Function and, Quality of Life with CP can provide valuable insights into the musculoskeletal consequences of motor impairments and guide interventions to improve bone health.
Statement of the problem Is there a relation between Bone Mineral Density, Gross Motor Function and Quality of Life in children with CP ? Purpose of the study
To study the relationship between:
- Bone Mineral Density and Gross Motor Function in ambulant and non-ambulant CP children.
- Bone Mineral Density and Quality of Life in ambulant and non-ambulant CP children.
- Gross Motor Function and Quality of Life in ambulant and non-ambulant CP children.
Detailed description
Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuro pathologic lesion is non-progressive, children with cerebral palsy may develop a range of secondary conditions over time that will variably affect their functional abilities. The prevalence of CP varies between 1.5 to more than 4 cases per 1,000 live births worldwide. The motor impairments associated with CP can range from mild to severe, affecting different muscle groups and leading to difficulties in activities of daily living and participation in social and recreational activities.
Children with CP often experience motor impairments that affect their gross motor function, leading to limitations in activities and participation. These motor impairments can also have a negative impact on bone health, resulting in reduced bone mineral density (BMD) and increased risk of skeletal complications.
Gross motor function (GMF) refers to the ability to perform coordinated movements using large muscle groups, such as walking, running, and jumping. It is a key aspect of physical ability and independence in daily activities for children with CP. Previous research has shown that gross motor function is closely associated with bone health in this population. However, further investigation is needed to explore the specific nature of this correlation and its implications for intervention strategies.
Gross motor function is commonly assessed using standardized tools such as the Gross Motor Function Classification System (GMFCS) or the Gross Motor Function Measure (GMFM). Quality of life is a multidimensional construct that encompasses physical, psychological, and social well-being. In the context of cerebral palsy, understanding the impact of gross motor function on quality of life is crucial for comprehensive care and intervention planning. Children with CP may face limitations in mobility, participation in activities, and social interactions, which can significantly affect their overall quality of life. Exploring the relationship between gross motor function and quality of life can provide valuable insights into the factors influencing the holistic well-being of children with CP.
The quality of life in children with CP is not only influenced by their motor function but also by their overall health and well-being. Bone health plays a crucial role in maintaining the physical abilities and independence of individuals, as well as their overall quality of life. Impaired bone health in children with CP can lead to limitations in mobility, increased pain, and reduced participation in activities, which can have a significant impact on their overall well-being.
Bone mineral density, on the other hand, is an important measure of bone strength and overall skeletal health. Children with CP often exhibit lower BMD compared to typically developing peers due to factors such as reduced weight-bearing activities, muscle weakness, altered biomechanics, limited mobility, and hormonal imbalances. This reduced BMD increases their susceptibility to fractures and skeletal deformities, further impacting their functional abilities and quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Ambulant ) | – | Other: Group 1consisted of 37 children with CP classified to level I, II and III according to GMFCS., then: 1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD). 2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function. 3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). |
| Group 2 (Non-Ambulant ) | – | Other: Group 2consisted of 38 children with CP classified to level IV and V according to GMFCS.then: 1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD). 2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function. 3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Seventy- five CP Children will be divided into two groups according to GMFCS: 1. Group 1 (Ambulant ) consisted of 35 children with CP classified to level I, II and III according to GMFCS. 2. Group 2 (Non-Ambulant ) consisted of 35 children with CP classified to level IV and V according to GMFCS. All measured variables will be identified for children of both groups, then correlation between BMD, gross motor function and QoL will be determined.
Key inclusion criteria (5 listed)
- Children with CP (spastic diplegia and quadriplegia).
- Their chronological ages will be ranged from 7 to 10 years.
- They will be selected from both genders.
- Their motor function will be at any Level according to GMFCS.
- Their body mass index (BMI ) will be normal.
Key exclusion criteria (8 listed)
- Underweight, Overweight or Obese.
- Epilepsy , kidney problems that make them taking hormonal treatments or drugs affect bone density or taking calcium, vitamin D, steroids during 6 months prior to the study.
- Fracture in the measurement areas.
- Hip Flexion deformity more than 30° when posed to measure.
- Internal metallic fixations in the measurement areas (neck of femur and lumber vertebra from L1-L4).
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 |
|---|---|---|
| Group 1Also: Ambulantconsisted of 37 children with CP classified to level I, II and III according to GMFCS., then: Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD). Gross motor function measurement scale (GMFM) will be used to assess gross motor function. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). | Other | Group 1 (Ambulant ) |
| Group 2Also: Non-Ambulantconsisted of 38 children with CP classified to level IV and V according to GMFCS. then: Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD). Gross motor function measurement scale (GMFM) will be used to assess gross motor function. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL). | Other | Group 2 (Non-Ambulant ) |
Primary outcome
Dual-energy X-ray absorptiometry (DXA) scans
Time frame: 1 day
Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).
Gross motor function measurement scale (GMFM)
Time frame: 1 day
Gross motor function measurement scale (GMFM) will be used to assess gross motor function.
Quality of Life Questionnaire for Children (CP QOL-Child)
Time frame: 1 day
Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
Elham Elsayed Salem, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Bone Density, Low, run by Cairo University at 1 site in Egypt.
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 8 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shimaa Talaat Emara (01060279269, shimaaemara2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-energy X-ray absorptiometry (DXA) scans (time frame: 1 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 6 Mar 2024.