Anthropometric Measurements&Balance IN CP ChildrenNCT05139758
Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
A study testing Biodex Balane System in people with Anthropometric Measurements&Balance IN CP Children, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthropometric Measurements&Balance IN CP Children
- What is being tested?
- Biodex Balane System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2021to 28 Feb 2022
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Their age will be ranged from 8 to 12 years.
- The degree of their spasticity will be ranged from 1 to 2 according to Modified Ashworth' Scale.
- They will be on level Ⅰ and Ⅱ on Growth Motor Function Classification System (GMFCS).
- They will be able to stand without the use of an assistive device
- Children can follow instructions and understand given orders.
Who cannot join
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Walaa Abd El-Nabie, 201115606185
About this study
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Read the detailed description
- The European Society for Clinical Nutrition and Metabolism has pointed out that under-nutrition can led to change in body composition (e.g. depletion of body fat mass) and diminished function and outcome.
- The prevalence of under-nutrition in children with CP varies from 3.9 per cent to 71 percent mainly depending on the method of assessment, the severity of motor involvement and feeding problems.
- Studies indicate that children and adults with both mild and severe forms of CP have postural impairments. Dysfunctional posture control interferes with the activities of daily life .
- Children with CP may have impaired muscle tone and abnormal postural control, both of which affect functional balance capacity.
- There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
Knowledge of anthropometric measurements and whether they affect balance in children with CP will help clinicians to develop treatment programs which in turn will improve the overall balance and functional abilities of children with CP.
- Childeren age will be ranged from 8-12 years and on level Ⅰ and Ⅱ on Growth Motor Function Classification System
- Weight would be obtained on a digital scale (UNISCALE )
- Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece.
- CDC 2000 charts will be used to measure BMI
- The Biodex balance system will be used for the assessment of static and dynamic balance of all children
- Being tested
- Biodex Balane System
- Keywords
- ANTHROPOMETRIC MEASUREMENTS, BALANCE, CEREBRAL PALSY
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balane SystemDiagnostic test
The Biodex balance system will be used for the assessment of static and dynamic balance of all children in the current study.
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic cp | Experimental | it will be classified into two subgroups according to body mass index to underweight and healthy weight . Receives: Diagnostic Test: Biodex Balane System |
| diplegic cp | Experimental | it will be classified into two subgroups according to body mass index to underweight and healthy weight . Receives: Diagnostic Test: Biodex Balane System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there a correlation between anthropometric measurements and balance in children with cerebral palsy?
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start23 Aug 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Anthropometric Measurements&Balance IN CP ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ibrahim Ali Ibrahim, Cairo University
- Investigators
- Gehan El meniawy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139758
- Sponsor's protocol ID
- P.T.REC/012/003333
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan
Publications
Adamu AS, Sabo UA, Gwarzo GD, Belonwu RO. Nutritional status in cerebral palsy: A Cross-sectional comparative survey of children in Kano, Nigeria. Niger Postgrad Med J. 2018 Jul-Sep;25(3):156-160. doi: 10.4103/npmj.npmj_67_18.
PubMed 30264766Alvarez Zaragoza C, Vasquez Garibay EM, Garcia Contreras AA, Larrosa Haro A, Romero Velarde E, Rea Rosas A, Cabrales de Anda JL, Vega Olea I. Bone mineral density and nutritional status in children with quadriplegic cerebral palsy. Arch Osteoporos. 2018 Mar 4;13(1):17. doi: 10.1007/s11657-018-0434-8.
PubMed 29504042Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.
PubMed 23878204Aydog E, Bal A, Aydog ST, Cakci A. Evaluation of dynamic postural balance using the Biodex Stability System in rheumatoid arthritis patients. Clin Rheumatol. 2006 Jul;25(4):462-7. doi: 10.1007/s10067-005-0074-4. Epub 2005 Oct 25.
PubMed 16247584Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
PubMed 18055651Brooks J, Day S, Shavelle R, Strauss D. Low weight, morbidity, and mortality in children with cerebral palsy: new clinical growth charts. Pediatrics. 2011 Aug;128(2):e299-307. doi: 10.1542/peds.2010-2801. Epub 2011 Jul 18.
PubMed 21768315Bullock-Saxton JE. Local sensation changes and altered hip muscle function following severe ankle sprain. Phys Ther. 1994 Jan;74(1):17-28; discussion 28-31. doi: 10.1093/ptj/74.1.17.
PubMed 8265724Cumberworth VL, Patel NN, Rogers W, Kenyon GS. The maturation of balance in children. J Laryngol Otol. 2007 May;121(5):449-54. doi: 10.1017/S0022215106004051. Epub 2006 Nov 14.
PubMed 17105679Dawson N, Dzurino D, Karleskint M, Tucker J. Examining the reliability, correlation, and validity of commonly used assessment tools to measure balance. Health Sci Rep. 2018 Oct 27;1(12):e98. doi: 10.1002/hsr2.98. eCollection 2018 Dec.
PubMed 30623052Duran I, Martakis K, Rehberg M, Semler O, Schoenau E. Anthropometric measurements to identify undernutrition in children with cerebral palsy. Dev Med Child Neurol. 2019 Oct;61(10):1168-1174. doi: 10.1111/dmcn.14225. Epub 2019 Mar 29.
PubMed 30927269Gan SM, Tung LC, Tang YH, Wang CH. Psychometric properties of functional balance assessment in children with cerebral palsy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):745-53. doi: 10.1177/1545968308316474. Epub 2008 Jul 21.
PubMed 18645187Garcia Iniguez JA, Vasquez-Garibay EM, Garcia Contreras A, Romero-Velarde E, Troyo Sanroman R. Assessment of anthropometric indicators in children with cerebral palsy according to the type of motor dysfunction and reference standard. Nutr Hosp. 2017 Mar 30;34(2):315-322. doi: 10.20960/nh.353.
PubMed 28421784Gulati S, Sondhi V. Cerebral Palsy: An Overview. Indian J Pediatr. 2018 Nov;85(11):1006-1016. doi: 10.1007/s12098-017-2475-1. Epub 2017 Nov 20.
PubMed 29152685Haapala H, Peterson MD, Daunter A, Hurvitz EA. Agreement Between Actual Height and Estimated Height Using Segmental Limb Lengths for Individuals with Cerebral Palsy. Am J Phys Med Rehabil. 2015 Jul;94(7):539-46. doi: 10.1097/PHM.0000000000000205.
PubMed 25299521Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
PubMed 19329772
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05139758
- Acronym / sponsor ID
- P.T.REC/012/003333
- Keywords
- ANTHROPOMETRIC MEASUREMENTS, BALANCE, CEREBRAL PALSY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 1 Dec 2021 (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 purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Detailed description
- The European Society for Clinical Nutrition and Metabolism has pointed out that under-nutrition can led to change in body composition (e.g. depletion of body fat mass) and diminished function and outcome.
- The prevalence of under-nutrition in children with CP varies from 3.9 per cent to 71 percent mainly depending on the method of assessment, the severity of motor involvement and feeding problems.
- Studies indicate that children and adults with both mild and severe forms of CP have postural impairments. Dysfunctional posture control interferes with the activities of daily life .
- Children with CP may have impaired muscle tone and abnormal postural control, both of which affect functional balance capacity.
- There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
Knowledge of anthropometric measurements and whether they affect balance in children with CP will help clinicians to develop treatment programs which in turn will improve the overall balance and functional abilities of children with CP.
- Childeren age will be ranged from 8-12 years and on level Ⅰ and Ⅱ on Growth Motor Function Classification System
- Weight would be obtained on a digital scale (UNISCALE )
- Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece.
- CDC 2000 charts will be used to measure BMI
- The Biodex balance system will be used for the assessment of static and dynamic balance of all children
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemiplegic cp | Experimental | Diagnostic Test: Biodex Balane Systemit will be classified into two subgroups according to body mass index to underweight and healthy weight . |
| diplegic cp | Experimental | Diagnostic Test: Biodex Balane Systemit will be classified into two subgroups according to body mass index to underweight and healthy weight . |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Their age will be ranged from 8 to 12 years.
- The degree of their spasticity will be ranged from 1 to 2 according to Modified Ashworth' Scale.
- They will be on level Ⅰ and Ⅱ on Growth Motor Function Classification System (GMFCS).
- They will be able to stand without the use of an assistive device
- Children can follow instructions and understand given orders.
Key exclusion criteria (3 listed)
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
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 |
|---|---|---|
| Biodex Balane SystemThe Biodex balance system will be used for the assessment of static and dynamic balance of all children in the current study. | Diagnostic test | diplegic cp, hemiplegic cp |
Primary outcome
Is there a correlation between anthropometric measurements and balance in children with cerebral palsy?
Time frame: 6 months
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Background: PubMed 30264766Adamu AS, Sabo UA, Gwarzo GD, Belonwu RO. Nutritional status in cerebral palsy: A Cross-sectional comparative survey of children in Kano, Nigeria. Niger Postgrad Med J. 2018 Jul-Sep;25(3):156-160. doi: 10.4103/npmj.npmj_67_18.
- Background: PubMed 29504042Alvarez Zaragoza C, Vasquez Garibay EM, Garcia Contreras AA, Larrosa Haro A, Romero Velarde E, Rea Rosas A, Cabrales de Anda JL, Vega Olea I. Bone mineral density and nutritional status in children with quadriplegic cerebral palsy. Arch Osteoporos. 2018 Mar 4;13(1):17. doi: 10.1007/s11657-018-0434-8.
- Background: PubMed 23878204Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.
- Background: PubMed 16247584Aydog E, Bal A, Aydog ST, Cakci A. Evaluation of dynamic postural balance using the Biodex Stability System in rheumatoid arthritis patients. Clin Rheumatol. 2006 Jul;25(4):462-7. doi: 10.1007/s10067-005-0074-4. Epub 2005 Oct 25.
- Background: PubMed 18055651Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
- Background: PubMed 21768315Brooks J, Day S, Shavelle R, Strauss D. Low weight, morbidity, and mortality in children with cerebral palsy: new clinical growth charts. Pediatrics. 2011 Aug;128(2):e299-307. doi: 10.1542/peds.2010-2801. Epub 2011 Jul 18.
- Background: PubMed 8265724Bullock-Saxton JE. Local sensation changes and altered hip muscle function following severe ankle sprain. Phys Ther. 1994 Jan;74(1):17-28; discussion 28-31. doi: 10.1093/ptj/74.1.17.
- Background: PubMed 17105679Cumberworth VL, Patel NN, Rogers W, Kenyon GS. The maturation of balance in children. J Laryngol Otol. 2007 May;121(5):449-54. doi: 10.1017/S0022215106004051. Epub 2006 Nov 14.
- Background: PubMed 30623052Dawson N, Dzurino D, Karleskint M, Tucker J. Examining the reliability, correlation, and validity of commonly used assessment tools to measure balance. Health Sci Rep. 2018 Oct 27;1(12):e98. doi: 10.1002/hsr2.98. eCollection 2018 Dec.
- Background: PubMed 30927269Duran I, Martakis K, Rehberg M, Semler O, Schoenau E. Anthropometric measurements to identify undernutrition in children with cerebral palsy. Dev Med Child Neurol. 2019 Oct;61(10):1168-1174. doi: 10.1111/dmcn.14225. Epub 2019 Mar 29.
- Background: PubMed 18645187Gan SM, Tung LC, Tang YH, Wang CH. Psychometric properties of functional balance assessment in children with cerebral palsy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):745-53. doi: 10.1177/1545968308316474. Epub 2008 Jul 21.
- Background: PubMed 28421784Garcia Iniguez JA, Vasquez-Garibay EM, Garcia Contreras A, Romero-Velarde E, Troyo Sanroman R. Assessment of anthropometric indicators in children with cerebral palsy according to the type of motor dysfunction and reference standard. Nutr Hosp. 2017 Mar 30;34(2):315-322. doi: 10.20960/nh.353.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan
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.
Gehan El meniawy study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex Balane System in people with Anthropometric Measurements&Balance IN CP Children, 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 3 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 1 Dec 2021. 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 Walaa Abd El-Nabie (201115606185, aigmanutd7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there a correlation between anthropometric measurements and balance in children with cerebral palsy? (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139758, which also lists 39 linked publications.
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 1 Dec 2021.