Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With … (NCT06180395) | Clinical Trial Compass
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Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy
Egypt75 participantsStarted 2024-01-10
Plain-language 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.
Who can participate
Age range
7 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My child has cerebral palsy — would it be worth discussing whether DXA scanning to measure bone mineral density is something we should be doing as part of their routine care, regardless of this study?
2This trial is looking at how bone density relates to gross motor function using the GMFM scale — can you help me understand where my child currently falls on that scale, and whether that would be relevant to participating in or benefiting from this kind of research?
3The recruitment status for this trial is listed as unknown, so can you find out whether it is still actively enrolling children, and if not, whether there are similar observational studies we could look into?
4Since this study uses quality-of-life questionnaires designed specifically for children with cerebral palsy, like the CP QOL-Child, is that something our care team already tracks, and could the results from this trial eventually help guide my child's treatment plan?
5Given that this is an observational study rather than a treatment trial, what would my child actually experience if they participated — and are there any risks associated with the DXA scans used to measure bone density in children?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dual-energy X-ray absorptiometry (DXA) scans
Timeframe: 1 day
2
Gross motor function measurement scale (GMFM)
Timeframe: 1 day
3
Quality of Life Questionnaire for Children (CP QOL-Child)