- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381233
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
Status
Recruiting
Conditions
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
- Name: emad ismail, doctoral
- Phone Number: 01146808839
- Email: emad9111@live.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Emad
-
Contact:
- mohamed eldin, Ph.D
- Phone Number: 01064442032
- Email: omdamohamed9111@gmail.com
-
-
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: hemiplegic group
hemiplegic patient
|
assessment
assessment
assessment
|
Other: Group diaplegic
diaplegic patient
|
assessment
assessment
assessment
|
Other: group quadriplegic
quadriplegic patient
|
assessment
assessment
assessment
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 78093
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.
Clinical Trials on Evaluations
-
Tufts UniversityRecruiting
-
University Hospital, LilleBoehringer Ingelheim; HYLAB, Physiopathologie de l'exerciceCompletedRehabilitation | COPD | EvaluationsFrance
-
Peking University Third HospitalCompletedEvaluations, Diagnostic SelfChina
-
Tenon Hospital, ParisCompletedThe Performance Evaluations of the FloShield Defogging and Cleaning SystemFrance
-
Cairo UniversityUnknown
-
Cairo UniversityUnknown
-
Jewish General HospitalActive, not recruitingOlder People | Health Care | Health Impairment | EvaluationsCanada
-
HATİCE ÇETİNCompletedPain | Neck Pain | Evaluations, Diagnostic Self | Assessment, SelfTurkey
-
University Hospital, LilleCompletedCognitive Symptom | Evaluations, Diagnostic SelfFrance
Clinical Trials on Gross motor function classification System (GMFCS)
-
Hacettepe UniversityCompleted
-
Sanko UniversityCompletedCerebral Palsy | Gait, Hemiplegic | Gait, Spastic | Hemiplegic Cerebral Palsy | Cerebral Palsy Spastic DiplegiaTurkey
-
Marmara UniversityUnknown
-
Marmara UniversityUnknown
-
Gillette Children's Specialty HealthcareShriners Hospitals for ChildrenCompletedCerebral PalsyUnited States
-
Istanbul Kültür UniversityIstanbul UniversityCompleted
-
Gaziler Physical Medicine and Rehabilitation Education...Completed
-
Cairo UniversityCompleted
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; National Institute of Chemistry... and other collaboratorsCompletedCTNNB1 Gene MutationSlovenia, Australia
-
Abant Izzet Baysal UniversityNot yet recruitingDiplegic Cerebral Palsy