The Socioeconomic Status and Child Characteristics on the Physical Therapy Outcome in Children With Spastic Cerebral Palsy
Primary Purpose
C10.228.140.140.254
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
physical therapy intervention
Sponsored by
About this trial
This is an interventional diagnostic trial for C10.228.140.140.254 focused on measuring Cerebral palsy, spastic, motor function, socioeconomic status, progress, physical therapy
Eligibility Criteria
Inclusion Criteria:
- all children with spastic cerebral palsy under four years old age
Exclusion Criteria:
- with associated disorders, congenital anomalies, perceptual disorders, had IQ below 80% or had another diagnosis ( nerve lesion, genetic disorders).
Sites / Locations
- Zeinab Hussein
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
factors ( SES,age, sex,severity) and progress
Arm Description
the relation between progress in gross motor functions
Outcomes
Primary Outcome Measures
gross motor function measure
The Gross motor function measure (GMFM-88) is a valid clinical assessment tool designed to evaluate gross motor function, and its change over time in children with cerebral palsy (Russell, 2013). (GMFM-88) consists of 88 items in five dimensions A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), and E: Walking, Running and Jumping( 24 items). Each item was scored as 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, or not tested. The GMFM total scores is summation of the scores for all dimensions and dividing by 5. A percentage score was calculated for total score so it ranges from 0 to 100.
Secondary Outcome Measures
Full Information
NCT ID
NCT04160403
First Posted
November 9, 2019
Last Updated
January 13, 2020
Sponsor
Zeinab Hussein
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04160403
Brief Title
The Socioeconomic Status and Child Characteristics on the Physical Therapy Outcome in Children With Spastic Cerebral Palsy
Official Title
The Factors as Socioeconomic Status and Child Characteristics That May Impact on the Progress of Development After Physical Therapy Interventions in Children With Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
December 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zeinab Hussein
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main outcome of physical therapy interventions is the progress of gross motor functions which result from the interactions between many factors not limited to physical, medical or surgical interventions but also including child characteristics and socializing agents. Aim of the study: To determine the effect of socioeconomic status (SES), child characteristics (age, sex, severity, and type of cerebral palsy) on the progress of gross motor functions in children with cerebral palsy. Methods: Prospective cohort study on eighty children (44 boys, 36 girls) aging 3.11 ± 0.88 years old, diagnosed as spastic cerebral palsy. The gross motor function measure (GMFM-88) between two-time intervals with follow-up time 6 months Results: The median of the mean difference for the GMFM scores was related to socioeconomic status, age, sex, severity, and type of CP.
Detailed Description
This study had four stages, the first one make registry from a computer database of outpatient clinic faculty of physical therapy Cairo university for all children with cerebral palsy under four years old age. In the second stage the files of 100 children registered were studied to select spastic cerebral palsy without the following; associated disorders, congenital anomalies, perceptual disorders, IQ below 80%, or another diagnosis ( nerve lesion, genetic disorders). Before the evaluation stage, every parent of each selected child was aware with the purpose of the study and signed the written informed consent that was approved by the ethical committee faculty of Physical Therapy Cairo University.Evaluation
The 83 selected children were evaluated as follow:
Muscle tone assessment Modified Ashworth scale is a valid and reliable test for measure muscle tone (Mutlu, 2008) table 1. Then evaluate the tone distribution throughout the body to determine its type diplegia, quadriplegia, or hemiplegia.
Severity The gross motor function classification system (GMFCS) is a reliable and valid system to classify the children with CP according to their age- specific motor activity (Palisano, 2000). GMFCS is a time-independent variable and it has five levels of severity (I, II, III, IV &V). The children with level I& II grouped as mild cases, children with level III were moderate cases, and those with IV & V levels were sever cases.
The gross motor function measure The Gross motor function measure (GMFM-88) is a valid clinical assessment tool designed to evaluate gross motor function, and its change over time in children with cerebral palsy (Russell, 2013). (GMFM-88) consists of 88 items in five dimensions A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), and E: Walking, Running and Jumping( 24 items). Each item was scored as 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, or not tested. The GMFM total scores are a summation of the scores for all dimensions and dividing by 5. A percentage score was calculated for the total score so it ranges from 0 to 100.
Socioeconomic status (SES) SES was evaluated by a valid and updated of the socioeconomic status scale for health research in Egypt scale (El-Gilany, 2012). It includes 7 domains with a total score of 84 ; 1- education and cultural domain(for both husband & wife) (score = 30); 2- family domain (score = 10); 3- occupation domain(for both husband & wife) (score = 10); 4- Family possessions domain (score = 12); 5- home sanitation domain (score = 12); 6- health care domain (score = 5); 7- economic domain(score = 5). According to the quartiles of the score calculated, the socioeconomic level is classified into very low, low, middle and high levels.
Physical therapy program The trained physiotherapists did the physical therapy interventions based on neurodevelopmental technique (NDT) and strength training for all participated children in the study for three times per week along sex months. During the study, the parents were asked to be adhering to the sessions Follow up After 6 months of the physical therapy program, the GMFM88 for 80 children were evaluated again to determine the progress of motor functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C10.228.140.140.254
Keywords
Cerebral palsy, spastic, motor function, socioeconomic status, progress, physical therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective cohort study
Masking
None (Open Label)
Masking Description
the data about socioeconomic status did not be announced
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
factors ( SES,age, sex,severity) and progress
Arm Type
Experimental
Arm Description
the relation between progress in gross motor functions
Intervention Type
Other
Intervention Name(s)
physical therapy intervention
Other Intervention Name(s)
neurodevelopmental technique, strength training
Intervention Description
NDT bases on neuroplasticity by which the brain change and reorganize itself and its processes according to practice and experience by a) facilitation of normal postural alignment and movement patterns; b) inhibition of the involvement during developmental and functional activities; and c) using sensory feedback (manual contact, visual integration, somatosensory reinforcement) for recovering function
Primary Outcome Measure Information:
Title
gross motor function measure
Description
The Gross motor function measure (GMFM-88) is a valid clinical assessment tool designed to evaluate gross motor function, and its change over time in children with cerebral palsy (Russell, 2013). (GMFM-88) consists of 88 items in five dimensions A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), and E: Walking, Running and Jumping( 24 items). Each item was scored as 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, or not tested. The GMFM total scores is summation of the scores for all dimensions and dividing by 5. A percentage score was calculated for total score so it ranges from 0 to 100.
Time Frame
20 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all children with spastic cerebral palsy under four years old age
Exclusion Criteria:
with associated disorders, congenital anomalies, perceptual disorders, had IQ below 80% or had another diagnosis ( nerve lesion, genetic disorders).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeinab hussein
Organizational Affiliation
pediatric physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zeinab Hussein
City
Cairo
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
on line publication
IPD Sharing Time Frame
according to time of publication
Citations:
Citation
1. Mutch L, Alberman E, Hagberg B, et al. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992;34(6):547-51. [PubMed] [Google Scholar 2. Reeuwijk A, Van Schie PEM, Becher JG, et al. Effects of botulinum toxin type A on upper limb functions in children with cerebral palsy: a systematic review. Clin Rehabil. 2006;20(5):375-87. [PubMed] [Google Scholar]. 3. El-Tallawy, H. N., Farghaly, W. M., Shehata, G. A., Rageh, T. A., Metwally, N. A., Badry, R., … Kandil, M. R.. Cerebral palsy in Al-Quseir City, Egypt: prevalence, subtypes, and risk factors. Neuropsychiatric disease and treatment, 2014; 10, 1267-1272. 5- O'Shea TM, Preisser JS, Klinepeter KL, et al. Trends in mortality and cerebral palsy in a geographically based cohort of very low birth weight neonates born between1982 to 1994. Pediatrics. 1998;101(4 pt 1):642-[PubMed] [Google Scholar] 6- Shamsoddini AR, Hollisaz MT. Effect of sensory integration therapy on gross motor function in children with cerebral palsy. Iran J Child Neurology. 2009;3(1):43- 8. [Google Scholar] 7- McCullough N, Parkes J, Kerr C, McDowell BC(2013): The health of children and young people with cerebral palsy: a longitudinal, population-based study. Int J Nurs Stud. 50(6):747-756. [PubMed] [Google Scholar] 8- O'Shea, T. M. (2008). Diagnosis, treatment, and prevention of cerebral palsy in near-term/term infants. Clinical obstetrics and gynecology, 51(4), 816. 9- Saifi, S., & Mehmood, T. (2011). Effects of socio-economic status on students achievement. International Journal of Social Sciences and Education, 1(2), 119-128. 10- Braveman, P. A., Cubbin, C., Egerter, S., Chideya, S., Marchi, K. S., Metzler, M., & Posner, S. (2005). Socioeconomic status in health research: one size does not fit all. Jama, 294(22), 2879-2888. 11- Baker, E. H. (2014). Socioeconomic status, definition. The Wiley Blackwell Encyclopedia of health, illness, behavior, and society, 2210-2214. 12- Sundrum, R., Logan, S., Wallace, A., & Spencer, N. (2005). Cerebral palsy and socioeconomic status: a retrospective cohort study. Archives of disease in childhood, 90(1), 15-18. 13- Inchley, J. C., Currie, D. B., Todd, J. M., Akhtar, P. C., & Currie, C. E. (2005). Persistent socio-demographic differences in physical activity among Scottish schoolchildren 1990-2002. The European Journal of Public Health, 15(4), 386-388. 14- Myklebust G, Jahnsen R, Elkjaer S. (2009): Registration of interventions in children with cerebral palsy during three years-a population based study. [Scientific Poster Abstracts]. Developmental Medicine & Child Neurology. 51:65. doi: 10.1111/j.1469-8749.2009.03452_2.x 15- Palisano R, Begnoche DM, Chiarello LA, et al (2012): Amount and focus of physical therapy and occupational therapy for young children with cerebral palsy. Physical & occupational therapy in pediatrics. 32(4):368-82. doi: 10.3109/01942638.2012.715620. PubMed PMID: 22954372 16- Mutlu, A., Livanelioglu, A., & Gunel, M. K. (2008). Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC musculoskeletal disorders, 9(1), 44. 17- Palisano, R. J., Hanna, S. E., Rosenbaum, P. L., Russell, D. J., Walter, S. D., Wood, E. P., ... & Galuppi, B. E. (2000). Validation of a model of gross motor function for children with cerebral palsy. Physical therapy, 80(10), 974-985. 18- WHO. (2001). International classification of functioning, disability and health: ICF. (World HealthOrganization. 19- Law,M., & Darrah, J. (2014). Emerging therapy approaches: An emphasis on function. Journal of ChildNeurology, 29(8), 1101-1107. doi:10.1177/0883073814533151 20- Anttila, H., Autti-Rämö, I., Suoranta, J., Mäkelä, M., & Malmivaara, A. (2008). Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC pediatrics, 8(1), 14. 21- Russell, D. J., Rosenbaum, P. L., Wright, M., & Avery, L. M. (2013). Gross Motor Function Measure (GMFM-66 & GMFM-88) User's Manual. High Holborn, UK, Mac Keith Press. 22- El-Gilany, A., El-Wehady, A., & El-Wasify, M. (2012). Updating and validation of the socioeconomic status scale for health research in Egypt. Eastern Mediterranean Health Journal, 18(9). 23- Huitt, W., & Hummel, J. (2003). Piaget's theory of cognitive development. Educational psychology interactive, 3(2), 1-5. 24- Malik, F., & Marwaha, R. (2018). Development, Stages of Social Emotional Development In Children. In StatPearls [Internet]. StatPearls Publishing.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/books/NBK534819/
Description
selection of children
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/
Learn more about this trial
The Socioeconomic Status and Child Characteristics on the Physical Therapy Outcome in Children With Spastic Cerebral Palsy
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