Cerebral Palsy (CP)NCT06821815
Intensive Video-Based Game Therapy Applications in Cerebral Palsy
A study testing Video Game Based Therapy and Bimanual Intensive Therapy in people with Cerebral Palsy (CP), run by Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Video Game Based Therapy and Bimanual Intensive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cerebral Palsy Türkiye Foundation
Istanbul, Ataşehir
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: 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.
Read the detailed description
Cerebral Palsy (CP) is the most common physical disability observed in childhood. Due to the motor function losses observed in individuals with CP, their participation in activities is restricted. Rehabilitation approaches applied to develop motor skills and functional independence in individuals with CP are currently implemented with a target-oriented approach based on motor learning. In this context, video game-based rehabilitation programs are also frequently applied today. The principles of implementation, therapy durations, and session frequencies of motor learning-based rehabilitation approaches in CP rehabilitation vary in the literature. Most application methods are applied over a long period. However, nowadays, it is important to apply these therapy practices for a shorter duration but with high session frequency and intensity to achieve motor skill and functional independence goals in a shorter time.In light of this information, the study aims to investigate the effectiveness of an intensive video game-based rehabilitation program and an intensive bimanual activity-based therapy program for motor skills and daily living activities in individuals with CP. Applying video game-based rehabilitation programs in an intensive format to achieve the targeted functional improvements in upper extremity functions and motor skills in a short time and comparing the effectiveness of this approach with another intensive therapy program, while ensuring that the groups do not receive any other rehabilitation approach during the application period, makes our study unique. The study will include 20 children diagnosed with spastic cerebral palsy, aged 4-18, with Gross Motor Function Classification System (GMFCS) levels 1-2, Manual Ability Classification System (MACS) levels 1-3, who can follow given visual and verbal commands, Communication Function Classification System (CFCS) levels 1-2, Visual Function Classification System (VFCS) levels 1-2, who continue the program within the specified times, and who agree not to receive any therapy other than the one assigned randomly to their group during the study and sign the consent form. In the study, before, after, and 3 months after the 2-week rehabilitation program, assessments will be made using a demographic form, Gross Motor Function Measure-88 (GMFM-88), Canadian Occupational Performance Measure (COPM), Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT), Box \& Block Test, Upper Extremity Selective Motor Control Scale (SCUES), and Becure Balance System. The study group will receive a total of 28 sessions of intensive and structured video game-based rehabilitation, consisting of 20 individual sessions (5 days a week, 2 sessions per day, each session lasting 30-45 minutes) and 8 group training sessions over 2 weeks. The control group will also follow the same plan for 2 weeks, receiving a total of 28 sessions of intensive bimanual goal-oriented activity-based intervention. Care will be taken to ensure that the task contents applied between the two programs are similar to obtain objective results. The therapeutic approach determined and applied during this project, designed with exergames and serious games, is expected to guide professionals working in the field of CP. In this way, it will be possible to find solutions to patients' problems with the most effective and fastest treatment option and at a lower cost.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Video Game Based Therapy, Bimanual Intensive Therapy
- Keywords
- video game based therapy, cerebral palsy, bimanual therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Game Based TherapyOther
Also called Virtual Reality, Active Video Game, Exergame
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
Bimanual Intensive TherapyOther
This intervention includes goal directed activity based exercises for upper extremity functions. This intervention also includes exercises for postural control
| Study group | Role | What they receive |
|---|---|---|
| Video Game Based Therapy Group | Experimental | 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. Receives: Other: Video Game Based Therapy |
| Bimanual Intensive Therapy Group | Active comparator | 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. Receives: Other: Bimanual Intensive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function changes over the Study - Gross Motor Performance Measure - 88 (GMFM-88)
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
Measured: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
Performance of Activities of Daily Living - Canadian Occupational Performance Measure (COPM)
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.
Measured: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
Secondary outcomes (2)
Changes on Motor Function for Upper Extremities - Selective Control of the Upper Extremity Scale (SCUES)
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.
Measured: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
Changes on Motor Function for Upper Extremities - Box and Block Test
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.
Measured: Prior to the interventions, right after the 2 weeks of interventions and 2 months later as follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start10 Feb 2025
- Primary completion10 Oct 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Emir, Medipol University
- Investigators
- Ahmet Emir, Emir, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821815
- Sponsor's protocol ID
- E-10840098-202.3.02-7476
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are willing to share data of study, only by requests for meta analysis studies.
Publications
Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
PubMed 25527487
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive Video-Based Game Therapy Applications on Motor Skills, Daily Living Activities and Participation in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06821815
- Acronym / sponsor ID
- E-10840098-202.3.02-7476
- Conditions
- Cerebral Palsy (CP)
- Keywords
- video game based therapy, cerebral palsy, bimanual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cerebral Palsy (CP) is the most common physical disability observed in childhood. Due to the motor function losses observed in individuals with CP, their participation in activities is restricted. Rehabilitation approaches applied to develop motor skills and functional independence in individuals with CP are currently implemented with a target-oriented approach based on motor learning. In this context, video game-based rehabilitation programs are also frequently applied today. The principles of implementation, therapy durations, and session frequencies of motor learning-based rehabilitation approaches in CP rehabilitation vary in the literature. Most application methods are applied over a long period. However, nowadays, it is important to apply these therapy practices for a shorter duration but with high session frequency and intensity to achieve motor skill and functional independence goals in a shorter time.In light of this information, the study aims to investigate the effectiveness of an intensive video game-based rehabilitation program and an intensive bimanual activity-based therapy program for motor skills and daily living activities in individuals with CP. Applying video game-based rehabilitation programs in an intensive format to achieve the targeted functional improvements in upper extremity functions and motor skills in a short time and comparing the effectiveness of this approach with another intensive therapy program, while ensuring that the groups do not receive any other rehabilitation approach during the application period, makes our study unique. The study will include 20 children diagnosed with spastic cerebral palsy, aged 4-18, with Gross Motor Function Classification System (GMFCS) levels 1-2, Manual Ability Classification System (MACS) levels 1-3, who can follow given visual and verbal commands, Communication Function Classification System (CFCS) levels 1-2, Visual Function Classification System (VFCS) levels 1-2, who continue the program within the specified times, and who agree not to receive any therapy other than the one assigned randomly to their group during the study and sign the consent form. In the study, before, after, and 3 months after the 2-week rehabilitation program, assessments will be made using a demographic form, Gross Motor Function Measure-88 (GMFM-88), Canadian Occupational Performance Measure (COPM), Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT), Box \& Block Test, Upper Extremity Selective Motor Control Scale (SCUES), and Becure Balance System. The study group will receive a total of 28 sessions of intensive and structured video game-based rehabilitation, consisting of 20 individual sessions (5 days a week, 2 sessions per day, each session lasting 30-45 minutes) and 8 group training sessions over 2 weeks. The control group will also follow the same plan for 2 weeks, receiving a total of 28 sessions of intensive bimanual goal-oriented activity-based intervention. Care will be taken to ensure that the task contents applied between the two programs are similar to obtain objective results. The therapeutic approach determined and applied during this project, designed with exergames and serious games, is expected to guide professionals working in the field of CP. In this way, it will be possible to find solutions to patients' problems with the most effective and fastest treatment option and at a lower cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Game Based Therapy Group | Experimental | Other: Video Game Based TherapyIn 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. |
| Bimanual Intensive Therapy Group | Active comparator | Other: Bimanual Intensive TherapyIn 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Game Based TherapyAlso: Virtual Reality, Active Video Game, ExergameVideo 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 | Video Game Based Therapy Group |
| Bimanual Intensive TherapyThis intervention includes goal directed activity based exercises for upper extremity functions. This intervention also includes exercises for postural control | Other | Bimanual Intensive Therapy Group |
Primary outcome
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
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
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 25527487Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.
- Individual participant dataSharing planned: Undecided. We are willing to share data of study, only by requests for meta analysis studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Emir, Emir principal investigator
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Game Based Therapy and Bimanual Intensive Therapy in people with Cerebral Palsy (CP), run by Medipol University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.