NCT06516107

Brief Summary

PURPOSE: To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP. BACKGROUND: Cerebral palsy (CP) is considered the primary reason of motor impairment among children worldwide. Compared to parents of typically developing children, parents of children with cerebral palsy (CP) experience higher levels of stress and reduced quality of life (QoL). HYPOTHESES: There is no relation between the level of functional impairment among children with diplegic CP and their parental stress and QOL. RESEARCH QUESTION: Is there a relationship between the level of functional impairment among children with diplegic CP and the degree of their parental stress and quality of life?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

July 12, 2024

Last Update Submit

February 17, 2025

Conditions

Keywords

Cerebral palsyQuality of lifeParental stress

Outcome Measures

Primary Outcomes (1)

  • Parental stress

    Parental stress will be measured by the Arabic version of the parent stress index-short form (PSI-SF) . PSI-SF is a self-reported questionnaire with 36 items rated on a 5-point Likert scale (strongly agree or strongly disagree). The score of the measure ranged between 36 and 180, and a lower score indicates a better outcome.

    1 day - one session

Secondary Outcomes (2)

  • Quality of life of parents

    1 day - one session

  • Gross motor impairments

    1 day - one session

Study Arms (1)

1 Group of parents of children with diplegic cerebral palsy

Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP and were in a stable clinical and medical state will be included in this study. However, parents of children with behavioral problems, a history of ongoing heart disease, a botulinum toxin injection within the six months previous to the study, chronic chest disease, significant visual or auditory impairment, or parents with limited literacy will not allowed to participate in the study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Parents of Children with diplegic CP age range 2 to 4.5

You may qualify if:

  • Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP.
  • Parents of children with diplegic CP who were in a stable clinical and medical state.

You may not qualify if:

  • parents of children with behavioral problem.
  • a history of ongoing heart disease
  • a botulinum toxin injection within the six months previous to the study
  • chronic chest disease
  • significant visual or auditory impairment
  • parents with limited literacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai University

Ismailia, Egypt

Location

Related Publications (2)

  • Dubois-Comtois K, St-Onge J, St-Laurent D, Cyr C. Paternal distress and child behavior problems in low-SES families: Quality of father-child interactions as mediators. J Fam Psychol. 2021 Sep;35(6):725-734. doi: 10.1037/fam0000830. Epub 2021 Mar 11.

  • Villamor E, Tedroff K, Peterson M, Johansson S, Neovius M, Petersson G, Cnattingius S. Association Between Maternal Body Mass Index in Early Pregnancy and Incidence of Cerebral Palsy. JAMA. 2017 Mar 7;317(9):925-936. doi: 10.1001/jama.2017.0945.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at the Department of Physical Therapy for Pediatrics and Pediatric Surgery

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 23, 2024

Study Start

June 5, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations