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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation based structured home program applications
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring telerehabilitation, cerebral palsy, home program, participation, activity

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation based structured home program group

Routine physiotherapy and rehabilitation group

Arm 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 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
March 18, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04807790
Brief Title
Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" Chıldren With Cerebral Palsy
Acronym
(EoTBHPCP)
Official Title
Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" For The Improvement Of Motor Functıon, Activity And Participation In Pre-Schooler Chıldren With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
telerehabilitation, cerebral palsy, home program, participation, activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation based structured home program group
Arm Type
Experimental
Arm 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 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.
Arm Title
Routine physiotherapy and rehabilitation group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation based structured home program applications
Other Intervention Name(s)
Routine physiotherapy and rehabilitation group
Intervention 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 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.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure-88 (GMFM-88)
Description
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.
Time Frame
At baseline
Title
Quality of Upper Extremity Skills Test (QUEST)
Description
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.
Time Frame
At baseline
Other Pre-specified Outcome Measures:
Title
Segmental Assessment of Trunk Control (SATCO)
Description
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.
Time Frame
At baseline
Title
ABILHAND-KIDS
Description
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.
Time Frame
At baseline
Title
ABILOCO KIDS
Description
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.
Time Frame
At baseline
Title
Goal Attainment Scale (GAS)
Description
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.
Time Frame
At baseline
Title
LIFE-H
Description
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.
Time Frame
At baseline
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
At baseline
Title
Europian Child Environment Questionnaire ECEQ
Description
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.
Time Frame
At baseline
Title
Compliance of Parents of Children with Cerebral Palsy to Home Program Questionairre (CPHP-Q)
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being in preschool period (3-5 years old) Receiving routine physiotherapy and rehabilitation services 2 sessions in a week Family members being active mobile phone or computer and internet users Exclusion Criteria: Uncontrolled epileptic seizures Incomplete assesments Family's discontinuation of treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mintaze Kerem Günel, PhD
Phone
+905327164221
Email
mintaze@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sinem Asena Sel, Msc
Phone
+905382082460
Email
sinem.sel4@gmail.com
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mintaze Kerem Günel, PhD
Phone
05327164221
Email
mintaze@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sinem Asena Sel, Msc
First Name & Middle Initial & Last Name & Degree
Merve Tunçdemir, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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