EvaluationsNCT05381233
Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy
A study testing Gross motor function classification System (GMFCS), Arabic Version of Zarit burden Inventory measure and Arabic Version of Chalder Fatigue Scale (CFQ version 11) in people with Evaluations, run by Sara Shawki Mohamed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Evaluations
- What is being tested?
- Gross motor function classification System (GMFCS), Arabic Version of Zarit burden Inventory measure and Arabic Version of Chalder Fatigue Scale (CFQ version 11)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children wif congenital anomalies and chromosomal disease.
- Children wif recent musculoskeletal surgery.
- Any associated problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad
Cairo
mohamed eldin, Ph.D, 01064442032, omdamohamed9111@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Evaluations
- Being tested
- Gross motor function classification System (GMFCS), Arabic Version of Zarit burden Inventory measure, Arabic Version of Chalder Fatigue Scale (CFQ version 11)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross motor function classification System (GMFCS)Other
assessment
Arabic Version of Zarit burden Inventory measureOther
assessment
Arabic Version of Chalder Fatigue Scale (CFQ version 11)Other
assessment
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic group | Other | hemiplegic patient Receives: Other: Gross motor function classification System (GMFCS); Other: Arabic Version of Zarit burden Inventory measure; Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11) |
| Group diaplegic | Other | diaplegic patient Receives: Other: Gross motor function classification System (GMFCS); Other: Arabic Version of Zarit burden Inventory measure; Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11) |
| group quadriplegic | Other | quadriplegic patient Receives: Other: Gross motor function classification System (GMFCS); Other: Arabic Version of Zarit burden Inventory measure; Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Shawki Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Shawki Mohamed, October 6 University
- Investigators
- emad ismaiel, phd, Study director, physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381233
- Sponsor's protocol ID
- 78093
- Status last verified
- May 2022
- First submitted
- 4 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Functional Performance in Children With Spastic Cerebral Palsy in Relation to Care Burden and Fatigue of Their Mothers
- ClinicalTrials.gov ID
- NCT05381233
- Acronym / sponsor ID
- 78093
- Conditions
- Evaluations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sara Shawki MohamedUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hemiplegic group | Other | Other: Gross motor function classification System (GMFCS), Other: Arabic Version of Zarit burden Inventory measure, Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11)hemiplegic patient |
| Group diaplegic | Other | Other: Gross motor function classification System (GMFCS), Other: Arabic Version of Zarit burden Inventory measure, Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11)diaplegic patient |
| group quadriplegic | Other | Other: Gross motor function classification System (GMFCS), Other: Arabic Version of Zarit burden Inventory measure, Other: Arabic Version of Chalder Fatigue Scale (CFQ version 11)quadriplegic patient |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Children wif congenital anomalies and chromosomal disease.
- Children wif recent musculoskeletal surgery.
- Any associated problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gross motor function classification System (GMFCS)assessment | Other | Group diaplegic, group quadriplegic, hemiplegic group |
| Arabic Version of Zarit burden Inventory measureassessment | Other | Group diaplegic, group quadriplegic, hemiplegic group |
| Arabic Version of Chalder Fatigue Scale (CFQ version 11)assessment | Other | Group diaplegic, group quadriplegic, hemiplegic group |
Primary outcome
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Related trials for Evaluations
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emad ismaiel, phd study director
physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gross motor function classification System (GMFCS), Arabic Version of Zarit burden Inventory measure and Arabic Version of Chalder Fatigue Scale (CFQ version 11) in people with Evaluations, run by Sara Shawki Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emad ismail, doctoral (01146808839, emad9111@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function classification System (GMFCS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.