Clinical trial NCT06532513: Family-Centered Physiotherapy in Dyskinetic Cerebral Palsy
Official title: Examination of the Effects of Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application on Body Functions, Activity, Participation and Quality of Life in Severely Affected Children With Dyskinetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Gross Motor Function Measure-88; The Gross Motor Function Measure-66
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
Secondary outcomes:
measure: Dyskinesia Impairment Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Dyskinesia Impairment Mobility Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Dyskinetic Cerebral Palsy Functional Impact Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Gross Motor Function Classification System
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Manual Ability Classification System
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Communication Function Classification System
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Eating and Drinking Classification System
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the interventione
measure: Visual Function Classification System
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Goal Attainment Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Life-Habits Questionnaire
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: European Child Environment Questionnaire
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Parental Stress Scale
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
measure: Cerebral Palsy Quality of Life Questionnaire Child and Teen Palsy Quality of Life Questionnaire Child&Teen
timeFrame: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: EDA BURÇ
state: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ceren Günbey, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Eda Burç, MSc
role: STUDY_DIRECTOR
References: