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

NCT06180395 | Recruiting

• 1 other identifier: CairoU_STE
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy; Bone Density, Low; Gross Motor Development Delay

Outcome Measures

Primary Outcomes (3)

• Dual-energy X-ray absorptiometry (DXA) scans

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

  1 day

• Gross motor function measurement scale (GMFM)

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

  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).

  1 day

Study Arms (2)

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

Group 1 OTHER

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

Group 1 (Ambulant )

Group 2 OTHER

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

Group 2 (Non-Ambulant )

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine , Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elham Elsayed Salem, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Shimaa Talaat Emara

CONTACT

01060279269; shimaaemara2015@gmail.com

Alaa Fahmy AlNemr, PhD

CONTACT

0 100 372 7467; alaaalnemr28@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 22, 2023
• Study Start: January 10, 2024
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)