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RecruitingNCT06180395Updated Mar 6, 2024

Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy

An observational study in Cerebral Palsy, Bone Density, Low and Gross Motor Development Delay, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
75
Ages
7 Years to 10 Years
Sex
All
01

Study 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.

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:

  1. Bone Mineral Density and Gross Motor Function in ambulant and non-ambulant CP children.
  2. Bone Mineral Density and Quality of Life in ambulant and non-ambulant CP children.
  3. 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.

02

Conditions studied

  • Cerebral Palsy
  • Bone Density, Low
  • Gross Motor Development Delay
03

In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's planned enrollment of 75 is close to the median of 81 across 103 observational studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Children with CP (spastic diplegia and quadriplegia).
  2. Their chronological ages will be ranged from 7 to 10 years.
  3. They will be selected from both genders.
  4. Their motor function will be at any Level according to GMFCS.
  5. Their body mass index (BMI ) will be normal.

Exclusion criteria

Exclusion criteria

Children will be excluded from the study if they have any of the following :

  1. Underweight, Overweight or Obese.
  2. 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.
  3. Fracture in the measurement areas.
  4. Hip Flexion deformity more than 30° when posed to measure.
  5. Internal metallic fixations in the measurement areas (neck of femur and lumber vertebra from L1-L4).
  6. Hyperthyroidism or Hypothyroidism.
  7. Hypotonia.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

    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).

    Other: Group 2

Interventions

  • OtherGroup 1

    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).

    Also known as: Ambulant

  • OtherGroup 2

    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).

    Also known as: Non-Ambulant

06

What researchers measure

Primary outcomes

  1. Dual-energy X-ray absorptiometry (DXA) scans

    Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).

    Time frame: 1 day

  2. Gross motor function measurement scale (GMFM)

    Gross motor function measurement scale (GMFM) will be used to assess gross motor function.

    Time frame: 1 day

  3. 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).

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • faculty of medicine , Cairo University
    Giza, Egypt
    • shimaa Emara, M.Sc · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06180395
Lead sponsor
Cairo University
Responsible party
Shimaa Talaat Elsayed Emara (Principal Investigator, Cairo University) — Principal investigator
First posted
Dec 22, 2023
Start date
Jan 10, 2024
Primary completion
Mar 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Mar 6, 2024

Study contacts

Shimaa Talaat Emara
Contact
shimaaemara2015@gmail.com
01060279269
Alaa Fahmy AlNemr, PhD
Contact
alaaalnemr28@gmail.com
0 100 372 7467
Elham Elsayed Salem, professor
study chair · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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