- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06821815
Intensive Video-Based Game Therapy Applications in Cerebral Palsy
The Effect of Intensive Video-Based Game Therapy Applications on Motor Skills, Daily Living Activities and Participation in Cerebral Palsy
This study investigates the effectiveness of intensive video game-based rehabilitation and intensive bimanual activity-based therapy for improving motor skills and daily living activities in individuals with spastic cerebral palsy (CP). Given the importance of high-frequency, short-duration interventions in CP rehabilitation, the research compares these two approaches while ensuring participants receive no additional therapy during the study.
Twenty children (ages 4-18) with GMFCS levels 1-2 and MACS levels 1-3 will be randomly assigned to one of the two groups. The video game-based group will complete 28 structured sessions over two weeks, including 20 individual sessions and 8 group sessions. The control group will follow an identical schedule using bimanual goal-oriented activities. Assessments will be conducted before, after, and three months post-intervention using validated motor and functional performance measures.
By standardizing task contents between groups, the study aims to provide objective results and contribute to CP rehabilitation by identifying an effective, time-efficient, and cost-effective therapy option using exergames and serious games.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey (Türkiye)
- Cerebral Palsy Türkiye Foundation
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Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34815
- Istanbul Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with Spastic Cerebral Palsy
- Gross Motor Function Classification level I-II
- Manual Ability Classification level I-III
- Communication Function Classification System I-II
- No botox injections 6 months prior to the intervention
Exclusion Criteria:
- Visual problems which may effect the interventions
- Secondary conditions such as intellectual disability, epilepsy
- Having surgical procedure related to musculoskeletal system 1 year prior to he study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Game Based Therapy Group
In this group an Intensive video game based therapy program will be applied to participants.
Therapy program aimed for the motor function of upper extremities and postural control.
Therapy program includes 10 individual 4 group sessions per week, 28 sessions in total with each session lasts 40 minutes.
Total duration of this intervention is 2 weeks.
|
Video game based therapy interventions includes active video games for rehabilitation.
Leap Motion Controller based rehabilitative games, Xbox Kinect Games and Kinect Based Custom Rehabilitative Games will be applied to the participants
Other Names:
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|
Active Comparator: Bimanual Intensive Therapy Group
In this group an Bimanual Intensive therapy program will be applied to participants.
Therapy program aimed for the motor function of upper extremities and postural control.
Therapy program includes 10 individual 4 group sessions per week, 28 sessions in total with each session lasts 40 minutes.
Total duration of this intervention is 2 weeks.
|
This intervention includes goal directed activity based exercises for upper extremity functions.
This intervention also includes exercises for postural control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function changes over the Study - Gross Motor Performance Measure - 88 (GMFM-88)
Time Frame: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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GMFM-88 is a assessment tool to evaluate gross motor functions in children with cerebral palsy.
It evaluates motor functions in 5 dimensions and with 88 items total
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Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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Performance of Activities of Daily Living - Canadian Occupational Performance Measure (COPM)
Time Frame: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
|
The Canadian Occupational Performance Measure (COPM) is a client-centered assessment tool that evaluates self-perceived performance and satisfaction in daily activities across three areas: self-care, productivity, and leisure.
Clients identify up to five important but challenging activities and rate their performance and satisfaction on a 10-point scale (1 = extremely poor/not satisfied, 10 = excellent/completely satisfied).
The total performance and satisfaction scores are averaged separately, with higher scores indicating better function and greater satisfaction.
A change of 2 or more points is considered clinically significant.
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Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes on Motor Function for Upper Extremities - Selective Control of the Upper Extremity Scale (SCUES)
Time Frame: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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The Selective Control of the Upper Extremity Scale (SCUES) is a clinical tool used to assess selective motor control in the upper extremities of individuals with neurological impairments, particularly cerebral palsy (CP).
It evaluates a person's ability to voluntarily isolate and control specific upper limb movements without involuntary muscle activation.
SCUES assesses six movement patterns (shoulder flexion/extension, elbow flexion/extension, forearm supination/pronation, wrist flexion/extension) on a 3-point scale: 0 = no selective control, 1 = partial control, 2 = full selective control.
Scores from each movement are summed, with a higher total score indicating better selective motor control.
SCUES is useful for tracking motor function changes and evaluating the effectiveness of interventions aimed at improving upper limb movement in individuals with CP.
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Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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Changes on Motor Function for Upper Extremities - Box and Block Test
Time Frame: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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The Box and Block Test (BBT) is a standardized assessment used to measure manual dexterity and upper limb function in individuals with neurological impairments, including cerebral palsy (CP).
The test involves transferring as many small blocks as possible from one compartment of a box to another in 60 seconds, using one hand at a time.
The score is the total number of blocks successfully moved, with higher scores indicating better fine motor coordination, speed, and dexterity.
The BBT is widely used in rehabilitation to track motor function progress and evaluate the effectiveness of interventions targeting upper limb performance.
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Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Postural Control
Time Frame: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
|
The Becure balance system will be used for the Postural Control Assessment.
It is custom made assessment system uses wii balance board.
Centre of Gravity (COG) displacement and velocity of COG will be collected datas.
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Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Emir, Emir, Medipol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-7476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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