Family-Centered Physiotherapy in Dyskinetic Cerebral Palsy

NCT06532513 | Recruiting

• 1 other identifier: 2023/13-07 (KA-22031)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to examine the impact of family centered, goal-oriented physiotherapy and rehabilitation on body function, activity, participation, and quality of life in severely affected children with dyskinetic cerebral palsy (DCP). The first assessment was conducted and recorded for all patients at the beginning of the study. Subsequently, the study group was taught family centered physiotherapy practices in addition to routine physiotherapy for 10 weeks to be performed at home. The control group only received routine physiotherapy. Weekly remote monitoring, regular meetings, and a second assessment at the 10th week were conducted. The study concluded with all face-to-face assessments. According to the research protocol, the primary aim of this study was to evaluate the effectiveness of a 10-week family centered physiotherapy application. The goal of this intervention was to improve movement and posture, thereby enhancing daily activities and quality of life. The primary endpoint of the study was to determine the impact of family physiotherapy application taught to families during the 10-week education period. This study was conducted at the Faculty of Physical Therapy and Rehabilitation, Hacettepe University. This study aimed to structure and define a family centered, goal-oriented, personalized physiotherapy, and rehabilitation application for the treatment of children with cerebral palsy. One of the significant objectives of this study was to examine the effects of this intervention within the framework of the International Classification of Functioning, Disability, and Health (ICF) on body function, activity, participation, and quality of life. The study protocol started with evaluations from patients after obtaining approval from the ethics committees. The study will be completed within a follow-up period of four months without treatment, including the remote monitoring process. The results of this study aimed to provide valuable information about the effectiveness of family centered physiotherapy application in severely affected children with dyskinetic cerebral palsy.

Conditions

Cerebral Palsy, Dyskinetic

Keywords

Dyskinetic Cerebral Palsy; Family-Centered Care; Physiotherapy; Rehabilitation; Body Functions; Activities of Daily Living; Participation; Quality of Life; Children's Health; Motor Skills Disorders

Outcome Measures

Primary Outcomes (1)

• The Gross Motor Function Measure-88; The Gross Motor Function Measure-66

  The Gross Motor Function Measure-88 (GMFM-88) and its short form, the Gross Motor Function Measure-66( GMFM-66), assess gross motor function in children, especially those with cerebral palsy. KMFÖ-88 is widely used for comprehensive evaluations in clinical and research settings, whereas GMFM-66-66, a shorter version, focuses on activity measurement based on the International Classification of Functioning, Disability, and Health for Children and Youth (ICF-CY) to evaluate functional capacity in different positions and activities. A physiotherapist will conduct the assessment through clinical testing and video recordings will be independently evaluated by another researcher.

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

Secondary Outcomes (14)

• Dyskinesia Impairment Scale

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

• Dyskinesia Impairment Mobility Scale

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

• Wong-Baker Faces Pain Rating Scale

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

• Dyskinetic Cerebral Palsy Functional Impact Scale

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

• Gross Motor Function Classification System

  Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

Study Arms (2)

Experimental Group: Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application

EXPERIMENTAL

Participants in this group will receive routine physiotherapy and rehabilitation for 10 weeks, along with an additional 1-hour training for family centered goal-oriented physiotherapy and rehabilitation practices. Families will be instructed to perform these practices at home for 1 h every day.

Other: Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application

Control Group: Routine Physiotherapy and Rehabilitation Program

NO INTERVENTION

Participants in this group will undergo routine physiotherapy and rehabilitation for 10 weeks.

Interventions

Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application OTHER

Family centered goal-oriented physiotherapy and rehabilitation applications aim to enhance the functional level of severely affected children with dyskinetic cerebral palsy children through individualized activities conducted by family members at home. The program focuses on specific goals determined collaboratively by the family, physiotherapists, and physician, with regular monitoring and assessments to track progress.

Experimental Group: Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being in the age range of 5-18 years
• Having a diagnosis of Dyskinetic Cerebral Palsy (DSP) confirmed by a pediatric neurologist
• Being classified with a gross motor function level of IV-V using the Expanded and Revised Gross Motor Function Classification System (GMFCS E\&R)
• Having a Manual Ability Classification System (MACS) classification of manual ability level IV-V
• Having a Communication Function Classification System (CFCS) communication function level of I-II-III
• For volunteers participating through Zoom and Whatsapp applications, having computer literacy and these applications installed on their devices
• e. Continuing routine physiotherapy and rehabilitation programs.

You may not qualify if:

• Having difficulty understanding and following instructions
• Having severe visual impairments
• Having undergone orthopedic or brain surgery interventions in the last 12 months.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

EDA BURÇ

Ankara, Hacettepe University, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ceren Günbey, PhD

  Hacettepe University

  STUDY DIRECTOR

• Eda Burç, MSc

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Mintaze Kerem Günel, PhD

CONTACT

+905327164221; mintaze@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pt, PhD, prof.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 1, 2024
• Study Start: October 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)