Clinical trial NCT05709080: Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden
Official title: Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Collaborative Intervention Process
Functional Goals Achievement
Keywords: Family-professional collaboration
partnerships
children's performance
quality of life
burden
caregivers
physical therapists
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to examine the effect of implanting the family-professional collaboration practice model on the functional goals achievement of children with CP and their caregivers' quality of life and burden. The children will be treated by physical therapists who will be assigned to two groups (control and experimental).

Detailed description: A randomized, single-blinded control study involved 28 physical therapists and 44 pairs of children with CP aged 2-12 years old and their caregivers will be assigned randomly into experimental and control groups. Physical therapists in the experimental group will receive two instructional sessions (3 hours each) to implement collaboration during the therapy sessions and physical therapists in the control group will receive no instructions. Children will receive 45- 60 minutes therapy sessions (5 sessions/week) for six weeks. Goal Attainment Scaling (GAS) to measure the children's goals achievement change rate, the Arabic version of the World Health Organization Quality of Life Brief (WHOQOL- Brief) to examine the caregivers' quality of life, and the Zarit Burden Interview Arabic Abridged version (ZBI-A) to evaluate the caregivers' burden will be used.

Eligibility criteria: Inclusion Criteria:

* Physical therapists with at least one year of experience in pediatric physical therapy.
* Children with CP, aged between 2 to 12 years, Gross Motor Function Classification System (GMFCS) level I, II, and III, and attended the physical therapy sessions accompanied by their caregivers.

Exclusion Criteria:

* Physical therapists in the experimental group who rate their level of confidence to implement the collaborative strategies less than 4 out of 5.
* children who underwent recent surgery (6 months) or after Botulinum toxin injection treatment (3 months), had uncontrolled seizure disorder, or discontinued physical therapy sessions.

Primary outcomes:
measure: Goals Attainments Scale (assessing change of the goals achievement from base line data)
timeFrame: the goals will be identified in the end of the first session( first week) , re-assessment session conducted on the beginning of the session (15) in the third week , and final assessment was conducted in the beginning of the session (30)in the sixth week
measure: World health organization quality of life- Brief assessing change of the quality of life from base line data)
timeFrame: the children's caregiver will fill the WHOQOL-Brief questionnaire twice, in the beginning of the first session in the first week and at end of the session (30) last sessionsin the sixth week
measure: Zarit Burden Interview- Arabic Abridged version assessing change of the burden from base line data)
timeFrame: the children's caregiver will fill the ZBI-A questionnaire twice, in the beginning of the first session in the first week and at end of the session (30) last session in the sixth week
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References: