Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy

NCT06251531 | Completed

• 1 other identifier: Ergo.21269652
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

play, child, intervention

Outcome Measures

Primary Outcomes (4)

• The Canadian Occupational Performance Measure (COPM)

  It was used to identify children's occupational problems and determine the goals of play. The COPM is a patient-reported, semi-structured assessment for individuals aged 8 years and over; it is used for goal-setting and planning interventions (18). The participants who were older than 8 years were asked to answer by themselves, and participants who were under 8 years answered both by themselves and parent proxy to identify and score occupational performance problems experienced in self-care, productivity, and leisure. In comparing initial and final values, a change of at least 2 points indicates clinical significance (19,20). The Turkish validity and reliability was established by Torpil et al (20).

  30 minutes

• Pediatric Evaluation of Disability Inventory (PEDI)

  It was used to evaluate functional performance and disability level.PEDI contains 3 scales : Functional Skills Scale (FSS) that identifies clinical patterns of current skills in functional skill attainment; Caregiver Assistance Scale that indirectly measures capability and evaluates actual performance by assesing the extent of help a parent provides in daily functioning, and Modifications scale which was not used in current study. The FSS consists of self-care, mobility, and social function, including the ICF's activity and participation. It consist 197 items in total devided as 73 items in self care, 59 items in mobility and 65 items in social function. Each item is scored as unable (0) or able (1). The caregiver assistance scale measures the caregiver support with a Likert-type rating (0-5). PEDI is sensitive to show clinical changes that can guide the therapist in defining the functional level of children with CP (21-22). The Turkish validity and reliability was established (22).

  30 minutes

• Gross Motor Function Classification System (GMFCS)

  The GMFCS was used for classify motor functions of participants. The GMFCS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish GMFCS is valid and reliable.

  15 minutes

• Manual Ability Classification System (MACS)

  The MACS was used for classify manuel functions of participants. The MACS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish MACS is valid and reliable.

  15 minutes

Study Arms (2)

GD-TG-PBI

EXPERIMENTAL

Goal-Directed Therapist-Guided Play-Based Intervention

Other: Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)

Control Group

NO INTERVENTION

Routine therapy

Interventions

Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) OTHER

The GD-TG-PBI used play to improve performance in targeted functional activities. The program was planned by a physiotherapist with 25 years' experience and an occupational therapist with six years' experience in play. The sessions were based on motor-learning principles supporting cortical plasticity. Individual-specific goals were transformed into play activities that increase occupational participation with regard to the child's abilities, needs, and learning potential. A top-down approach based on direct gamification was adapted without dividing it into components, instead of a component-based, bottom-up approach. Thus, a structured play program was created and an individual-specific intervention was applied in line with the occupational goals and detailed motor evaluations. Positive, active experiences facilitated the adaptation of the learned skills to daily life.

Also known as: Goal-Directed Therapist-Guided Play-Based Intervention

GD-TG-PBI

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Ruya Gul Temel: lead

Study Sites (2)

Rüya Gül Temel

Ankara, Etimesgut, 6145, Turkey (Türkiye)

Location

Rüya Gül Temel

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: February 9, 2024
• Study Start: January 18, 2019
• Primary Completion: June 20, 2019
• Study Completion: December 17, 2020
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)