NCT04938063

Brief Summary

  1. 1.To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress.
  2. 2.To detect the correlation between the PS level to the different domains of ADL limitation.
  3. 3.To determine the substantial factors that underlying the parents' stress of those diplegic CP children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

June 18, 2021

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessing the change in parent stress

    It will be assessed by using the approved Arabic version of the Parent stress index. The parent will be asked to read each statement carefully and focus on each statement and circle the one that best suites his psychological state concerning his child. Parents should respond by circling SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). They should circle only one response per item, and make an "X" through the response if it needs to be changed. Parents must not erase any answers. Parent must be Encouraged to answer all the items.

    Baseline only

  • Assessing the change in children's quality of life

    It will be assessed by The Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module version 2 It is composed of parent proxy-report forms obtainable in numerous international languages including Arabic. The Arabic version of the PedsQL™ Family Impact Module version 2.0 is a parent report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family .It consists of 36 items comprising 8 dimensions. It includes 6 subscales measuring parents' self-reported functioning: Physical Functioning (6 items), Emotional Functioning (5items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items) and Worry (5 items); as well as 2 subscales measuring parent- reported family functioning: Daily Activities (3 items) and Family Relationships (5 items)

    Baseline only

  • Assessing the change in children's activities of daily living

    It will be carried out by using self-care domain (eating, grooming, bathing, dressing upper and lower body and toileting), transfer and locomotion domains of the WeeFIM. Assessment should be performed by direct observing the child. However, when direct observation is not possible, interviewing parents who are familiar with the child's everyday activities is crucial

    Baseline only

Study Arms (1)

Cerebral palsy children

Sample size estimation was carried out to determine the recruited number of the diplegic CP children from the outpatient clinic at the Faculty of Physical Therapy, Cairo University, Physical Therapy Department at the National Institute of Neuromotor Disorder, Abu El-Reesh Hospital, and private physiotherapy clinics. The age of patients will range from 18 months to 5 years old. Both sexes will participate in this study

Other: Assessing the correlation between Functional Impairment and Parenting Stress

Interventions

Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy

Cerebral palsy children

Eligibility Criteria

Age18 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Sample size estimation was carried out to determine the recruited number of the diplegic CP children from the outpatient clinic at the Faculty of Physical Therapy, Cairo University, Physical Therapy Department at the National Institute of Neuromotor Disorder, Abu El-Reesh Hospital, and private physiotherapy clinics. The age of patients will range from 18 months to 5 years old. Both sexes will participate in this study.

You may qualify if:

  • Diplegic CP children.
  • Their age ranges from 18 months to five years old.
  • All levels of GMFCS will be included.
  • Both sexes will be included.
  • All children were medically and clinically stable.
  • Parents must be able to write and read.

You may not qualify if:

  • Diplegic CP children, who might have one or more of the following:
  • History of chronic cardiac or chest disease.
  • Any behavioral disorders.
  • Current hospitalization for urgent medical reasons.
  • Significant visual or auditory impairment.
  • Previous history of Botox injection within last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ahmed Fekry

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 24, 2021

Study Start

January 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 15, 2021

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations