Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" Chıldren With Cerebral Palsy ((EoTBHPCP))

Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" For The Improvement Of Motor Functıon, Activity And Participation In Pre-Schooler Chıldren With Cerebral Palsy

The aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Telerehabilitation based structured home program applications

Detailed Description

The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities child can't do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.

After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.

During routine physiotherapy and rehabilitation practices, activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. Telerehabilitation-based structured home program applications, which are given in addition to routine physiotherapy and rehabilitation applications, and only individuals who receive routine physiotherapy and rehabilitation will be followed for 24 weeks. Individuals who receive routine physiotherapy and rehabilitation will be monitored only for control purposes, and a structured home program will be given to the group that receives Telerehabilitation Based Structured Home Program Practices, which are given in addition to routine physiotherapy and rehabilitation applications. The researcher will not be included in the program of the group that only benefits from routine physiotherapy and rehabilitation practices. A total of three evaluations will be made for both groups, after the training before the training and after 12 weeks from the training.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06080
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Being in preschool period (3-5 years old)
2. Receiving routine physiotherapy and rehabilitation services 2 sessions in a week
3. Family members being active mobile phone or computer and internet users

Exclusion Criteria:

1. Uncontrolled epileptic seizures
2. Incomplete assesments
3. Family's discontinuation of treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation based structured home program group; The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.	Other: Telerehabilitation based structured home program applications; The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided. After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.; Other Names: Routine physiotherapy and rehabilitation group
No Intervention: Routine physiotherapy and rehabilitation group; Routine physiotherapy and rehabilitation practices, consist of activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure-88 (GMFM-88)	GMFM-66 is a widely used scale to show the improvement in motor function. The KMFM-88 evaluates the motor functional structure in five main positions: supine and prone lying and rolling (A), sitting (B), crawling and kneeling (C), standing (D), walking, running and jumping (E). The highest score is 100, the lowest score is 0.	At baseline
Quality of Upper Extremity Skills Test (QUEST)	It is used to evaluate the upper extremity motor functions of children. QUEST is a test that evaluates the quality of movement and dexterity of the child with SP. QUEST is concerned with how the child does the activity he or she can do. Examines the quality of upper limb skills in 7 sections. The highest score is 100, the lowest score is 50.	At baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Segmental Assessment of Trunk Control (SATCO)	It is used to evaluate trunk postural control in children with CP. Examines 7 levels of body control with and without support at C7, T3, T11, L3 and Pelvis level. The highest score is 20, the lowest score is 1.	At baseline
ABILHAND-KIDS	It evaluates hand skills in children with CP according to the activity frames of ICF-CY. It consists of 21 items. The highest score is 20, the lowest score is 0.	At baseline
ABILOCO KIDS	It is a scale that evaluates the walking ability of children with CP according to the activity frame of ICF-CY. . 10 maddeden oluşmaktadır. The highest score is 20, the lowest score is 0.	At baseline
Goal Attainment Scale (GAS)	It is used to evaluate the effect of individualized, goal directed physiotherapy and rehabilitation programs for children with CP. In order to measure the effect of the treatment, specific goals for the child are determined together with the family, child and experts. Goals; It is graded at five levels, from -2 to 2.	At baseline
LIFE-H	It has been developed to evaluate the participation in life of children with CP. It consists of 11 sub-headings: nutrition, physical fitness, personal care, mobility, interpersonal communication, social roles, education, recreational activities, responsibilities, housing, and social life. The highest score is 10, the lowest score is 0.	At baseline
Canadian Occupational Performance Measure	It is used to evaluate activity performance and satisfaction levels in individuals. This assessment scale is a measure that determines the problems faced by individuals in the field of activity performance through a semi-structured interview. This measurement evaluates the activity performance problems of individuals with the performance and satisfaction scores they give themselves. The highest score is 10, the lowest score is 0.	At baseline
Europian Child Environment Questionnaire ECEQ	It was created in order to evaluate the environmental factors in children with CP and to determine the needs and accessibility to the needs. It is a valid (ICC> 0.95) scale consisting of 60 questions that evaluate the conditions in home, school and social life under three main sub-headings: physical environment, social support and attitudes. Scored "0: Not required", "1: Necessary and mostly accessible", "2: Required but mostly unavailable" to determine need and availability.	At baseline
Compliance of Parents of Children with Cerebral Palsy to Home Program Questionairre (CPHP-Q)	It is a scale that examines the reasons for parents with children with CP between the ages of 2 and 18 not to adapt to the home program within the scope of personal and environmental factors. Scale items were created under the umbrella of ICF-CY frame. It has proven to be highly valid and reliable. It consists of 22 items. The highest score is 110, the lowest score is 22.	At baseline

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cerebral palsy; telerehabilitation; activity; participation; home program
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: KA- 20124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No