Caregiver Burden in Cerebral Palsy Undergoing Hip and Knee Surgery

NCT06224322 | Unknown

• 1 other identifier: 2234234
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are: Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.

Conditions

Cerebral Palsy; Care Giving Burden

Outcome Measures

Primary Outcomes (1)

• Zarit Caregiven Burden scale

  The 22-item instrument is included in this scale. Each item in the questionnaire is a statement that the carer is asked to confirm using a 5-point scale. The answer options range from 0 (Never) to 4 (Almost Always).

  Preoperative, Postoperative three, six and twelve month

Secondary Outcomes (1)

• Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module

  Preoperative, Postoperative three, six and twelve month

Study Arms (1)

Cerebral Palsy Patients Parent

Parents of patients who underwent knee and hip surgery for cerebral palsy

Other: Assesment Scale

Interventions

Assesment Scale OTHER

Caregiving burden will be assessed with Turkish validated scoring tools such as the Zarit scale and the Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module before and after surgery.

Also known as: Questionnaire

Cerebral Palsy Patients Parent

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Our study will be conducted with the parents of children with cerebral palsy who are admitted to the Orthopaedics Unit of Istanbul Medical Faculty and will be operated on in the knee-hip region.

You may qualify if:

• Parent Age
• a. Being in the 20-60 age group.
• Diagnosis
• Having a child with clinically diagnosed cerebral palsy
• The movement scale of the cerebral palsy patient is between GMFS 3 and 5
• A minimum follow-up of 12 months after surgery
• The primary carer is the mother or father

You may not qualify if:

• The patient and his/her family have been lost to follow-up
• Having another disabled person in need of care in the family
• Family's unwillingness to participate in the study
• Loss of a parent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey

Istanbul, Fatih-Topkapı, 34080, Turkey (Türkiye)

RECRUITING

Istanbul Unıversity Medicine Faculty Orthopaedic Department

Istanbul, Fatih, 34080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Caregiver Burden

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mehmet MD Demirel, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Muçteba AM Yıldırım, Fellow

CONTACT

+090 534 3038472; mucceba@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: June 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)