NCT05381233

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

April 4, 2022

Last Update Submit

May 15, 2022

Conditions

Evaluations

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    3 months

Study Arms (3)

hemiplegic group

OTHER

hemiplegic patient

Other: Gross motor function classification System (GMFCS)Other: Arabic Version of Zarit burden Inventory measureOther: Arabic Version of Chalder Fatigue Scale (CFQ version 11)

Group diaplegic

OTHER

diaplegic patient

Other: Gross motor function classification System (GMFCS)Other: Arabic Version of Zarit burden Inventory measureOther: Arabic Version of Chalder Fatigue Scale (CFQ version 11)

group quadriplegic

OTHER

quadriplegic patient

Other: Gross motor function classification System (GMFCS)Other: Arabic Version of Zarit burden Inventory measureOther: Arabic Version of Chalder Fatigue Scale (CFQ version 11)

Interventions

Gross motor function classification System (GMFCS)OTHER

assessment

Group diaplegicgroup quadriplegichemiplegic group
Arabic Version of Zarit burden Inventory measureOTHER

assessment

Group diaplegicgroup quadriplegichemiplegic group
Arabic Version of Chalder Fatigue Scale (CFQ version 11)OTHER

assessment

Group diaplegicgroup quadriplegichemiplegic group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Children wif congenital anomalies and chromosomal disease.
  • Children wif recent musculoskeletal surgery.
  • Any associated problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad

Cairo, Egypt

RECRUITING

Study Officials

  • emad ismaiel, phd

    physical therapy

    STUDY DIRECTOR

Central Study Contacts

emad ismail, doctoral

CONTACT

01146808839emad9111@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 4, 2022

First Posted

May 19, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2024

Study Completion

July 15, 2024

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

EG(1)