Clinical trial NCT06251531: Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy
Official title: The Effect of Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: play, child, intervention
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP).

Materials and Methods: This study was designed as a randomized controlled trial. 34 children with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children were classified according to the Gross Motor Function Classification System (GMFCS) and the Manual Abilities Classification System (MACS). Participants were randomly divided into two groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI additional to routine therapy twice a week for 45 minutes per session during 8 weeks. Occupational performance and satisfaction were determined with the Canadian Occupational Performance Measure (COPM), and functional performance was evaluated with the Pediatric Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after the intervention for both groups. Dİfferences between COPM and PEDI values before and after the intervention calculated, additionally the effect size of each parameter calculated.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of the study were a spastic DCP diagnosis, being aged 4-12 years, Gross Motor Function Classification System (GMFCS) level I, II or III, and Manual Ability Classification System (MACS) level I or II, and ability to follow verbal instructions.

Exclusion Criteria:

* The exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (NDT), surgical intervention or Botulinum Toxin injection in the last six months, diagnosis of psychiatric disorder accompanying CP, vision and/or hearing problems affecting participation.

Primary outcomes:
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: 30 minutes
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: 30 minutes
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: 15 minutes
measure: Manual Ability Classification System (MACS)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Rüya Gül Temel
state: Etimesgut
city: Ankara
country: Turkey
facility: Rüya Gül Temel
Study officials:
References: