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Video-game Based Therapy in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-game based therapy
Conventional physiotherapy
Sponsored by
Gaziantep Islam Science and Technology University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Virtual reality, Video games, Upper extremity, Rehabilitation

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Cerebral Palsy voluntary participation, Age between 4-18 years GMFCS Level I-II-III MACS Level I-II-III Exclusion Criteria: Not voluntary to participate in the research, Botox in the last 6 months, Upper limb or spine surgeries in the last 6 months

Sites / Locations

  • Demet Gözaçan Karabulut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video-game based therapy group

Conventional physiotherapy group

Arm Description

The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy).

The conventional physiotherapy group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes).

Outcomes

Primary Outcome Measures

Gross Motor Function Classification System (GMFCS)
Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
Manuel ability classification system (MACS)
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function
Change from Baseline ABILHAND-Kids at 8 weeks
Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.
Change from Baseline Selective Control of the Upper Extremity Scale (SCUES) at 8 weeks
It is a practical and useful assessment tool developed to evaluate upper extremity selective motor control. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better selective motor control.
Change from Baseline Clinometer at 8 weeks
Caliper clinometer (App Development) is a phone application used to measure angle changes in the relevant region. In the evaluation of shoulder and elbow proprioception change will be evaluated.
Change from Baseline Entertainment Scale at 8 weeks
The entertainment level of sessions and therapy training for individuals will be evaluated with a 0-10 point numerical rating scale (entertainment scale). There are numbers from 0 to 10 on the horizontal line of 10 cm. 0 "Not fun" on the line in the scale; 10 represents "a lot of fun". Entertainment rating will be recorded numerically from 0 to 10.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
October 20, 2023
Sponsor
Gaziantep Islam Science and Technology University
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1. Study Identification

Unique Protocol Identification Number
NCT05846542
Brief Title
Video-game Based Therapy in Cerebral Palsy
Official Title
Effects of Video-game Based Therapy on Upper Extremity Selective Motor Control and Proprioception in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziantep Islam Science and Technology 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
The video-based therapy applications; will be applied in a non-three-dimensional (with desktop screen) way. In this application, there are different types of exercise programs that will work the upper extremity movements. The video-based therapy applications will be applied to individuals with Cerebral Palsy (CP) who will be included in the study with the Xbox Kinect 3600 (Microsoft, Washington, USA) device. This study was planned to examine the effect of video-based therapy on upper extremity selective motor control and proprioception in individuals with Cerebral Palsy.
Detailed Description
Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS. The eligible participants will be allocated two groups, including video-game based therapy group and conventional physiotherapy control group. All the assessments will be performed before and after the therapy in the 8-week therapy groups.The control group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes). The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy). All sessions will be performed in the clinic with the specialist physiotherapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Virtual reality, Video games, Upper extremity, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video-game based therapy group
Arm Type
Experimental
Arm Description
The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy).
Arm Title
Conventional physiotherapy group
Arm Type
Active Comparator
Arm Description
The conventional physiotherapy group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes).
Intervention Type
Other
Intervention Name(s)
Video-game based therapy
Intervention Description
Video-game based therapy will be designed for the individual basis for the upper extremity.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Conventional physiotherapy within a specific program
Primary Outcome Measure Information:
Title
Gross Motor Function Classification System (GMFCS)
Description
Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
Time Frame
At Baseline
Title
Manuel ability classification system (MACS)
Description
This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function
Time Frame
At Baseline
Title
Change from Baseline ABILHAND-Kids at 8 weeks
Description
Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline Selective Control of the Upper Extremity Scale (SCUES) at 8 weeks
Description
It is a practical and useful assessment tool developed to evaluate upper extremity selective motor control. The administration of the SCUES required patients to perform specific isolated movement patterns at various levels including: shoulder (abduction/adduction); elbow (flexion/extension); forearm (supination/pronation); wrist (flexion/extension); and fingers/thumb (grasp/release). The total score of the SCUES ranges between 0 and 15 and higher scores indicate better selective motor control.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline Clinometer at 8 weeks
Description
Caliper clinometer (App Development) is a phone application used to measure angle changes in the relevant region. In the evaluation of shoulder and elbow proprioception change will be evaluated.
Time Frame
Change from Baseline at 8 weeks
Title
Change from Baseline Entertainment Scale at 8 weeks
Description
The entertainment level of sessions and therapy training for individuals will be evaluated with a 0-10 point numerical rating scale (entertainment scale). There are numbers from 0 to 10 on the horizontal line of 10 cm. 0 "Not fun" on the line in the scale; 10 represents "a lot of fun". Entertainment rating will be recorded numerically from 0 to 10.
Time Frame
Change from Baseline at 8 weeks

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: Diagnosis of Cerebral Palsy voluntary participation, Age between 4-18 years GMFCS Level I-II-III MACS Level I-II-III Exclusion Criteria: Not voluntary to participate in the research, Botox in the last 6 months, Upper limb or spine surgeries in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demet Gözaçan Karabulut
Organizational Affiliation
Gaziantep Islam Science and Technology University
Official's Role
Study Director
Facility Information:
Facility Name
Demet Gözaçan Karabulut
City
Gaziantep
State/Province
None Selected
ZIP/Postal Code
27010
Country
Turkey

12. IPD Sharing Statement

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Video-game Based Therapy in Cerebral Palsy

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