Back to resultsQuality of Life and Functional Performance in Children With Spastic Cerebral Palsy
Primary Purpose
Evaluations
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gross motor function classification System (GMFCS)
Arabic Version of Zarit burden Inventory measure
Arabic Version of Chalder Fatigue Scale (CFQ version 11)
Sponsored by
About this trial
This is an interventional other trial for Evaluations
Eligibility Criteria
Inclusion Criteria:
- Age older then 18 years.
- there BMI will be ranged from 18.5 too 24.9 kg/m2 (Misra et al., 2009) .
- They are the main caregiver for there children.
- They are of low or middle socioeconomic status according too socioeconomic status scale (El-Gilany et al., 2012).
- Having at least 7months of experience in taking care of the child.
- They have no congenital spinal anomalies or lower limb deformities.
Exclusion Criteria:
- Children wif congenital anomalies and chromosomal disease.
- Children wif recent musculoskeletal surgery.
- Any associated problems.
Sites / Locations
- EmadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
hemiplegic group
Group diaplegic
group quadriplegic
Arm Description
hemiplegic patient
diaplegic patient
quadriplegic patient
Outcomes
Primary Outcome Measures
Gross motor function classification System (GMFCS)
Which are a Standardized method too, classify gross motor function in children with (CP) aged from 2 too, 18years. Teh GMFCS are a 5-level system designed too, reflect differences in gross motor function that are meaningful in teh daily lives of children with CP and there families, with an emphasis on sitting and walking. A classification are made by determining which level best corresponds too, a child"s present gross motor function (Palisano et al., 1997). dis scale will be used for detecting teh CP child functional performance level
Arabic Version of Zarit burden Inventory measure
It are one of the most commonly used measures of caregiver burden (Knight et al., 2000). The care burden of all the participants will be evaluated by the Zarit burden Inventory measures (ZBI). The ZBI assesses the stress suffered by those whom give care too the persons in need. Initially developed and validated more TEMPthan 25 years ago (Zarit et al., 1980)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381233
Brief Title
Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy
Official Title
Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy in Relation to Care Burden and Fatigue of Their Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Shawki Mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Caregiver Burden (CB) is expressed as a multidimensional response related to caregiving, including physical, psychological, emotional, social, and economic problems and has been identified as a public health concern. All these factors negatively affect caregiver health and indirectly affect the care of the disabled child .To provide better support for parents of children with CP, we must understand the difficulties faced those parents and identify the key and common areas where assistance can be rendered.
Detailed Description
The symptoms of CP vary from person to person. A person with severe CP might need to use special equipment to be able to walk, or might not be able to walk at all and might need lifelong care. A person with mild CP, on the other hand, might walk a little awkwardly, but might not need any special help. CP does not get worse over time, though the exact symptoms can change over a person's lifetime.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hemiplegic group
Arm Type
Other
Arm Description
hemiplegic patient
Arm Title
Group diaplegic
Arm Type
Other
Arm Description
diaplegic patient
Arm Title
group quadriplegic
Arm Type
Other
Arm Description
quadriplegic patient
Intervention Type
Other
Intervention Name(s)
Gross motor function classification System (GMFCS)
Intervention Description
assessment
Intervention Type
Other
Intervention Name(s)
Arabic Version of Zarit burden Inventory measure
Intervention Description
assessment
Intervention Type
Other
Intervention Name(s)
Arabic Version of Chalder Fatigue Scale (CFQ version 11)
Intervention Description
assessment
Primary Outcome Measure Information:
Title
Gross motor function classification System (GMFCS)
Description
Which are a Standardized method too, classify gross motor function in children with (CP) aged from 2 too, 18years. Teh GMFCS are a 5-level system designed too, reflect differences in gross motor function that are meaningful in teh daily lives of children with CP and there families, with an emphasis on sitting and walking. A classification are made by determining which level best corresponds too, a child"s present gross motor function (Palisano et al., 1997). dis scale will be used for detecting teh CP child functional performance level
Time Frame
3 months
Title
Arabic Version of Zarit burden Inventory measure
Description
It are one of the most commonly used measures of caregiver burden (Knight et al., 2000). The care burden of all the participants will be evaluated by the Zarit burden Inventory measures (ZBI). The ZBI assesses the stress suffered by those whom give care too the persons in need. Initially developed and validated more TEMPthan 25 years ago (Zarit et al., 1980)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age older then 18 years.
there BMI will be ranged from 18.5 too 24.9 kg/m2 (Misra et al., 2009) .
They are the main caregiver for there children.
They are of low or middle socioeconomic status according too socioeconomic status scale (El-Gilany et al., 2012).
Having at least 7months of experience in taking care of the child.
They have no congenital spinal anomalies or lower limb deformities.
Exclusion Criteria:
Children wif congenital anomalies and chromosomal disease.
Children wif recent musculoskeletal surgery.
Any associated problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emad ismail, doctoral
Phone
01146808839
Email
emad9111@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emad ismaiel, phd
Organizational Affiliation
physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Emad
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed eldin, Ph.D
Phone
01064442032
Email
omdamohamed9111@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy
We'll reach out to this number within 24 hrs