Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy

May 15, 2022 updated by: Sara Shawki Mohamed

Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy in Relation to Care Burden and Fatigue of Their Mothers

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross motor function classification System (GMFCS)
Time Frame: 3 months
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
3 months
Arabic Version of Zarit burden Inventory measure
Time Frame: 3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: emad ismaiel, phd, Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

July 15, 2024

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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