Clinical trial NCT04160403: 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
Overall status: COMPLETED
Phase: NA
Conditions: C10.228.140.140.254
Keywords: Cerebral palsy, spastic, motor function, socioeconomic status, progress, physical therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-11-13
Enrollment: 80
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: DIAGNOSTIC

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:

1. 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.
2. 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.
3. 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.
4. 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.

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).

Primary outcomes:
measure: gross motor function measure
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Zeinab Hussein
state: Dokki
Study officials:
affiliation: pediatric physical therapy
name: zeinab hussein
role: PRINCIPAL_INVESTIGATOR
References:
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