Family-Centered Physiotherapy in Dyskinetic Cerebral Palsy

NCT ID: NCT06532513

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-07-01

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.

Detailed Description

This study aimed to investigate the impact of family centered goal-directed physiotherapy and rehabilitation intervention on body function, activities, participation, and quality of life in children with severely affected dyskinetic cerebral palsy. Within this scope, an intervention program was designed to enhance children's functional performance in their daily life activities. The focal points of this research included pain, fatigue, sleep problems, and parental stress levels. The goal of this intervention was to improve children's movement and posture, increase their independence in daily life activities, and enhance their overall quality of life. This study aimed to assess the effectiveness of family centered interventions in children with cerebral palsy.

Conditions

Cerebral Palsy, Dyskinetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application

Intervention Type: 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.

Control Group: Routine Physiotherapy and Rehabilitation Program

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Being in the age range of 5-18 years

2. Having a diagnosis of Dyskinetic Cerebral Palsy (DSP) confirmed by a pediatric neurologist

3. Being classified with a gross motor function level of IV-V using the Expanded and Revised Gross Motor Function Classification System (GMFCS E&R)

4. Having a Manual Ability Classification System (MACS) classification of manual ability level IV-V

5. Having a Communication Function Classification System (CFCS) communication function level of I-II-III

6. 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.

Exclusion Criteria

1. Having difficulty understanding and following instructions

2. Having severe visual impairments

3. Having undergone orthopedic or brain surgery interventions in the last 12 months.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Mintaze Kerem Gunel

pt, PhD, prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ceren Günbey, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Eda Burç, MSc

Role: STUDY_DIRECTOR

Hacettepe University

Locations

EDA BURÇ

Ankara, Hacettepe University, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Mintaze Kerem Günel, PhD

Role: CONTACT

mintaze@hacettepe.edu.tr

+905327164221 ext. 03123051577

Facility Contacts

MİNTAZE KEREM GÜNEL, PhD

Role: primary

mintaze@hacettepe.edu.tr

+905327164221

Eda Burç, MSc

Role: backup

eda_burc_1994@hotmail.com

905327164221

Other Identifiers

2023/13-07 (KA-22031)

Identifier Type: -

Identifier Source: org_study_id