Comparison of the Effects of Video-based Games Applied to Individuals With Cerebral Palsy in Different Age Groups on Balance, Trunk Proprioception, Motivation and Quality of Life
Primary Purpose
CP (Cerebral Palsy)
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Microsoft Kinect 360
Pediatric Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for CP (Cerebral Palsy)
Eligibility Criteria
Inclusion Criteria: Being diagnosed with spastic type CP with bilateral and unilateral involvement Volunteer to participate in the study Be between the ages of 4-18 Being at 1/2 level according to Gross Motor Function Classification System Cooperate with assessments Cooperating with virtual reality therapy Exclusion Criteria: Botulinum toxin administration in the last 6 months Having had any surgical operation in the last 6 months
Sites / Locations
- Hatay Mustafa Kemal ÜniversitesiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Study Group- 4-11 age
Control Group-4-11 age
Study Group- 11-18 age
Control Group-11-18 age
Arm Description
Outcomes
Primary Outcome Measures
Pediatric Berg Balance Test
The Pediatric Berg Balance Scale is a modified version of the Berg Balance Scale used to assess functional balance skills in school-aged children.Patients are evaluated out of 56 points, with the highest score being 56. Change will be evaluated
One Leg Standing Test
The one-leg stance test is a test in which the time to stand on balance is measured on the right and left extremities of the patient, and evaluates the static balance. Change will be evaluated.
Caliper Clinometer
Caliper inclinometer is a phone protractor application used to measure angle changes in the relevant region. In the evaluation of trunk proprioception, the person is in a sitting position with the back unsupported and the feet not touching the ground, while the arms are positioned crossed on the trunk. Change will be evaluated
Pediatric Motivation Scale
The scale consists of 21 items divided into 6 subsections (effort-importance, interest-pleasure, competence, relationship, autonomy, value-benefit) and enables the evaluation of the child's motivation towards the rehabilitation program from her own perspective.The total score is 119. The higher the score, the higher the motivation. Change will be evaluated.
Pediatric quality of life questionere pedsQL for Children
The Children's Quality of Life Scale was developed to measure the quality of life of children and adolescents aged 2-18.It is scored between 0-100, with the highest score being 100. Change will be evaluated
Secondary Outcome Measures
Full Information
NCT ID
NCT05667792
First Posted
August 1, 2022
Last Updated
January 12, 2023
Sponsor
Mustafa Kemal University
1. Study Identification
Unique Protocol Identification Number
NCT05667792
Brief Title
Comparison of the Effects of Video-based Games Applied to Individuals With Cerebral Palsy in Different Age Groups on Balance, Trunk Proprioception, Motivation and Quality of Life
Official Title
Comparison of the Effects of Video-based Games Applied to Individuals With Cerebral Palsy in Different Age Groups on Balance, Trunk Proprioception, Motivation and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In the study we planned, 44 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-10 will be included in the child group, and individuals aged 11-18 will be included in the adolescent group. Individuals with cerebral palsy in the child and adolescent group will also be randomized and divided into treatment and control groups. In addition to the conventional treatment created in accordance with neurodevelopmental treatment approaches, video-based virtual reality games will be played for a total of 10 weeks for treatment groups in both age groups. The patients will be followed up with a video-based game application for an average of 15 minutes, after the physiotherapy and rehabilitation application, which consists of an average of 45 minutes, twice a week. Individuals in the control group in both age groups will be followed for 10 weeks with conventional treatment created in accordance with neurodevelopmental treatment approaches.
The entire sample will be evaluated at the beginning of the study and at the end of the 10th week. Our main aim in the study is to compare the effects of video-based games applied in different age groups on balance, trunk proprioception, motivation and quality of life.
Detailed Description
A total of 44 patients with cerebral palsy who agreed to participate in the study, 22 patients between the ages of 4-10 and 22 patients between the ages of 11-18, will be included. Parents of the patients will be informed about the study.
44 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-10 will be included in the child group, and individuals aged 11-18 will be included in the adolescent group. Individuals with cerebral palsy in the child and adolescent group will also be randomized within themselves and divided into treatment and control groups. In addition to conventional treatment created in accordance with neurodevelopmental treatment approaches, video-based virtual reality games will be played for a total of 10 weeks for treatment groups in both age groups. The patients will be followed up with an average of 15 minutes of video-based games, after the physiotherapy and rehabilitation application, consisting of an average of 45 minutes, twice a week. Individuals in the control group in both age groups will be followed for 10 weeks with conventional treatment created in accordance with neurodevelopmental treatment approaches.
A treatment plan will be created for the entire sample group according to neurodevelopmental treatment approaches. In the content of the treatment plan; In order to regulate muscle tone and increase sensory input, intramuscular stretching and soft tissue mobilization, exercises that improve protective, balance and correction reactions, and support the development of postural control will be included. In addition, studies aimed at ensuring proper posture and increasing body awareness during standing without support, facilitation of trunk extension will be carried out. For the development of postural control in the same position, facilitation of trunk elongation and weight transfer to the affected and less affected side will be emphasized. Exercises will be performed on stepping and descending from the affected and less-affected side. Supported with appropriate hand grips, forward jumping with two feet, one foot, and weight transfer on one foot will be carried out.
In the evaluation of the patient, the pediatric motivation scale, balance, trunk proprioceptive sense and quality of life will be evaluated at the 1st and 10th weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CP (Cerebral Palsy)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group- 4-11 age
Arm Type
Experimental
Arm Title
Control Group-4-11 age
Arm Type
Placebo Comparator
Arm Title
Study Group- 11-18 age
Arm Type
Experimental
Arm Title
Control Group-11-18 age
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Microsoft Kinect 360
Intervention Description
Balance and trunk proprioception games will be selected and played for the children to be included in the treatment. Children will play these games with their own body movements.
Intervention Type
Other
Intervention Name(s)
Pediatric Rehabilitation
Intervention Description
Bobath therapy
Primary Outcome Measure Information:
Title
Pediatric Berg Balance Test
Description
The Pediatric Berg Balance Scale is a modified version of the Berg Balance Scale used to assess functional balance skills in school-aged children.Patients are evaluated out of 56 points, with the highest score being 56. Change will be evaluated
Time Frame
beginning and week 10
Title
One Leg Standing Test
Description
The one-leg stance test is a test in which the time to stand on balance is measured on the right and left extremities of the patient, and evaluates the static balance. Change will be evaluated.
Time Frame
beginning and week 10
Title
Caliper Clinometer
Description
Caliper inclinometer is a phone protractor application used to measure angle changes in the relevant region. In the evaluation of trunk proprioception, the person is in a sitting position with the back unsupported and the feet not touching the ground, while the arms are positioned crossed on the trunk. Change will be evaluated
Time Frame
beginning and week 10
Title
Pediatric Motivation Scale
Description
The scale consists of 21 items divided into 6 subsections (effort-importance, interest-pleasure, competence, relationship, autonomy, value-benefit) and enables the evaluation of the child's motivation towards the rehabilitation program from her own perspective.The total score is 119. The higher the score, the higher the motivation. Change will be evaluated.
Time Frame
beginning and week 10
Title
Pediatric quality of life questionere pedsQL for Children
Description
The Children's Quality of Life Scale was developed to measure the quality of life of children and adolescents aged 2-18.It is scored between 0-100, with the highest score being 100. Change will be evaluated
Time Frame
beginning and week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being diagnosed with spastic type CP with bilateral and unilateral involvement Volunteer to participate in the study Be between the ages of 4-18 Being at 1/2 level according to Gross Motor Function Classification System Cooperate with assessments Cooperating with virtual reality therapy
Exclusion Criteria:
Botulinum toxin administration in the last 6 months Having had any surgical operation in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İlkan Çiçek
Phone
+90 55481456
Email
ilkancicek97@gmail.com
Facility Information:
Facility Name
Hatay Mustafa Kemal Üniversitesi
City
Antakya
State/Province
Hatay
ZIP/Postal Code
31000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yılmaz Akbaş, doctoral lecturer
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of the Effects of Video-based Games Applied to Individuals With Cerebral Palsy in Different Age Groups on Balance, Trunk Proprioception, Motivation and Quality of Life
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