Cerebral PalsyNCT06071182
Task-oriented Game Therapy Using Enhances Functions in Children With Cerebral Palsy.
A study testing Task-oriented Fruit ninja game in people with Cerebral Palsy, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy is an umbrella definition that refers to a disorder that occurs after a problem affecting a person's brain functions and has symptoms such as sensory, motor and mental deficits. Cerebral Palsy can cause serious functional losses in individuals. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Task-oriented Fruit ninja game
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2023to 15 Nov 2023
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being diagnosed with Cerebral Palsy with a doctor's report (Based on patient reports)
- Being between the ages of 6-18
- Having upper extremity involvement
- Being between levels 1-3 on the Expanded Gross Motor Function Classification (GMFS)
- Having the mental competence to understand the game being played
Who cannot join
- Those whose family did not sign a participation consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Task-oriented Game Therapy Using Free Internet-videogame Enhances Upper Extremity Functions for Children With Cerebral Palsy: A Sham-controlled Study.
Cerebral Palsy is an umbrella definition that refers to a disorder that occurs after a problem affecting a person's brain functions and has symptoms such as sensory, motor and mental deficits. Cerebral Palsy can cause serious functional losses in individuals. Various rehabilitation approaches have been developed and used to eliminate these functional losses. One of these approaches is a therapy technique called Task-oriented therapy, which focuses on completing tasks that mostly involve functional activities that the participating individuals do actively and repeatedly. There are various ways to perform task-oriented therapy. These can be achieved by motivating the individual to perform various tasks (cutting with scissors, buttoning, putting on and taking off legos, etc.) in an active, intense and repetitive manner, as well as through games played on devices such as tablet computers that have emerged with the developing technology. Thanks to their Android and touch features, such devices can motivate people to use their upper extremities functionally. Thanks to such applications, rehabilitation practices can be made more fun and effective results can be obtained. In the literature, it was seen that video game-based rehabilitation practices were used in individuals with cerebral palsy, but their effects on balance were mostly evaluated. Its effect on upper extremity functional capacity was mostly limited to feasibility studies. For these reasons, there is no data in the literature on this subject with quality results. The main purpose of this study is to determine whether upper extremity functional capacity can be improved by using the Tablet PC-based Fruit ninja game, which is easily accessible today, in the rehabilitation of individuals with cerebral palsy, using objective measurement tools.
Read the detailed description
This study is a sham-controlled prospective non-invasive field study. A total of 22 participants were pre-registered for the study. However, when the inclusion criteria were applied, 4 participants whose GMFCS score was not between levels 1-3 but met other conditions were excluded from the study without taking preliminary measurements. A total of 18 participants were included in the study by taking preliminary measurements. Participants were randomly distributed (Computerized randomization (random.org)) into a nine-person study group and a placebo control group.
Traditional physiotherapy (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions of passive stretching for the shoulder (bilateral), 2-directional and 1 set of 10 repetitions of passive stretching at the elbow level) was applied to the study group for 30 minutes a day, twice a week for 4 weeks, and then Fruit ninja game was played on the tablet for 20 minutes a day, twice a week.
The control group was treated with traditional physiotherapy (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretching for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretching at the elbow level) for 30 minutes a day, twice a week for 4 weeks. For placebo purposes, the fruit ninja game playing video (https://www.youtube.com/watch?v=cAb0cAviA1s) was watched on the same tablet for 3 minutes a day, twice a week, for 4 weeks, and the movements in the game were repeated for 2 minutes on a flat and smooth table. Wrist movements were performed.
The first measurements of the participants participating in the study were taken after their last session the week before the study, as they came to rehabilitation twice a week, and their last measurements were taken after their last session in the 4th week and before their first session the following week. During this period, the participants' families were contacted to ensure that their children did not exercise or play any computer games at home. Measurements were carried out by the assistant researcher. Rehabilitation practices were carried out by the principal investigator and assistant investigator.
- Conditions
- Cerebral Palsy
- Being tested
- Task-oriented Fruit ninja game, sham-controlled therapy
- Keywords
- Therapy, Rehabilitataion, Video game
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented Fruit ninja gameDevice
The fruit ninja game were played from tablet PC 20 minutes in a day and 2 times in a week for 4 weeks
sham-controlled therapyOther
The fruit ninja game playing video (https://www.youtube.com/watch?v=cAb0cAviA1s) was watched on the same tablet for 3 minutes a day, twice a week, for 4 weeks, and the wrist and wrist exercises were repeated for 2 minutes on a flat and smooth table. movements were made.
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented therapy | Experimental | Traditional physiotherapy for 30 minutes a day, twice a week for 4 weeks (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretches for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretches at the elbow level) + 2 times a week a day Fruit ninja game on tablet in 20 minutes Receives: Device: Task-oriented Fruit ninja game |
| Sham-controlled | Sham comparator | Same time traditional therapy + 5 minutes sham intervention Receives: Other: sham-controlled therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Dexterity
Box and Block test is used. It is a measurement tool that measures gross comprehension skills. The number of cubes thrown one by one from one compartment to the other within 1 minute of a two-compartment box containing 150 cubes with dimensions of 2.5 cm*2.5 cm*2.5 cm is evaluated. It is done separately for right and left hands.
Measured: The change from baseline box and block test score at week 4
Hand function
Nine Hole Peg test is used It is a scale that evaluates participants functionally. It measures the time it takes to attach and remove 9 thin rods to a panel with 9 holes on it with the desired hand and return it to its box.
Measured: The change from baseline nine hole peg test score at week 4
Grip strength
Analog dinamometer is used. Three times maximal grip strength is measured for both hands.
Measured: The change from baseline dinamometer score at week 4
Range of movement
Universal goniometers is used. Wrist flexion, wrist extension, radial and ulnar deviation scores (for both hands) are measured.
Measured: The change from baseline universal goniometer score at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start29 Jul 2023
- Primary completion21 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet SÖNMEZ, MSc, Study director, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071182
- Sponsor's protocol ID
- Mehmet.sonmez
- Status last verified
- Feb 2024
- First submitted
- 3 Oct 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Game Therapy Using Free Internet-videogame Enhances Upper Extremity Functions for Children With Cerebral Palsy: A Sham-controlled Study.
- ClinicalTrials.gov ID
- NCT06071182
- Acronym / sponsor ID
- Mehmet.sonmez
- Conditions
- Cerebral Palsy
- Keywords
- Therapy, Rehabilitataion, Video game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 6 Oct 2023 (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.
Cerebral Palsy is an umbrella definition that refers to a disorder that occurs after a problem affecting a person's brain functions and has symptoms such as sensory, motor and mental deficits. Cerebral Palsy can cause serious functional losses in individuals. Various rehabilitation approaches have been developed and used to eliminate these functional losses. One of these approaches is a therapy technique called Task-oriented therapy, which focuses on completing tasks that mostly involve functional activities that the participating individuals do actively and repeatedly. There are various ways to perform task-oriented therapy. These can be achieved by motivating the individual to perform various tasks (cutting with scissors, buttoning, putting on and taking off legos, etc.) in an active, intense and repetitive manner, as well as through games played on devices such as tablet computers that have emerged with the developing technology. Thanks to their Android and touch features, such devices can motivate people to use their upper extremities functionally. Thanks to such applications, rehabilitation practices can be made more fun and effective results can be obtained. In the literature, it was seen that video game-based rehabilitation practices were used in individuals with cerebral palsy, but their effects on balance were mostly evaluated. Its effect on upper extremity functional capacity was mostly limited to feasibility studies. For these reasons, there is no data in the literature on this subject with quality results. The main purpose of this study is to determine whether upper extremity functional capacity can be improved by using the Tablet PC-based Fruit ninja game, which is easily accessible today, in the rehabilitation of individuals with cerebral palsy, using objective measurement tools.
Detailed description
This study is a sham-controlled prospective non-invasive field study. A total of 22 participants were pre-registered for the study. However, when the inclusion criteria were applied, 4 participants whose GMFCS score was not between levels 1-3 but met other conditions were excluded from the study without taking preliminary measurements. A total of 18 participants were included in the study by taking preliminary measurements. Participants were randomly distributed (Computerized randomization (random.org)) into a nine-person study group and a placebo control group.
Traditional physiotherapy (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions of passive stretching for the shoulder (bilateral), 2-directional and 1 set of 10 repetitions of passive stretching at the elbow level) was applied to the study group for 30 minutes a day, twice a week for 4 weeks, and then Fruit ninja game was played on the tablet for 20 minutes a day, twice a week.
The control group was treated with traditional physiotherapy (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretching for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretching at the elbow level) for 30 minutes a day, twice a week for 4 weeks. For placebo purposes, the fruit ninja game playing video (https://www.youtube.com/watch?v=cAb0cAviA1s) was watched on the same tablet for 3 minutes a day, twice a week, for 4 weeks, and the movements in the game were repeated for 2 minutes on a flat and smooth table. Wrist movements were performed.
The first measurements of the participants participating in the study were taken after their last session the week before the study, as they came to rehabilitation twice a week, and their last measurements were taken after their last session in the 4th week and before their first session the following week. During this period, the participants' families were contacted to ensure that their children did not exercise or play any computer games at home. Measurements were carried out by the assistant researcher. Rehabilitation practices were carried out by the principal investigator and assistant investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented therapy | Experimental | Device: Task-oriented Fruit ninja gameTraditional physiotherapy for 30 minutes a day, twice a week for 4 weeks (Passive upper extremity Normal Joint Movements, 3-way and 1 set of 10 repetitions passive stretches for the shoulder (bilateral), 2-way, 1 set of 10 repetitions passive stretches at the elbow level) + 2 times a week a day Fruit ninja game on tablet in 20 minutes |
| Sham-controlled | Sham comparator | Other: sham-controlled therapySame time traditional therapy + 5 minutes sham intervention |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being diagnosed with Cerebral Palsy with a doctor's report (Based on patient reports)
- Being between the ages of 6-18
- Having upper extremity involvement
- Being between levels 1-3 on the Expanded Gross Motor Function Classification (GMFS)
- Having the mental competence to understand the game being played
Key exclusion criteria (1 listed)
- Those whose family did not sign a participation consent form
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 |
|---|---|---|
| Task-oriented Fruit ninja gameThe fruit ninja game were played from tablet PC 20 minutes in a day and 2 times in a week for 4 weeks | Device | Task-oriented therapy |
| sham-controlled therapyThe fruit ninja game playing video (https://www.youtube.com/watch?v=cAb0cAviA1s) was watched on the same tablet for 3 minutes a day, twice a week, for 4 weeks, and the wrist and wrist exercises were repeated for 2 minutes on a flat and smooth table. movements were made. | Other | Sham-controlled |
Primary outcome
Manual Dexterity
Time frame: The change from baseline box and block test score at week 4
Box and Block test is used. It is a measurement tool that measures gross comprehension skills. The number of cubes thrown one by one from one compartment to the other within 1 minute of a two-compartment box containing 150 cubes with dimensions of 2.5 cm*2.5 cm*2.5 cm is evaluated. It is done separately for right and left hands.
Hand function
Time frame: The change from baseline nine hole peg test score at week 4
Nine Hole Peg test is used It is a scale that evaluates participants functionally. It measures the time it takes to attach and remove 9 thin rods to a panel with 9 holes on it with the desired hand and return it to its box.
Grip strength
Time frame: The change from baseline dinamometer score at week 4
Analog dinamometer is used. Three times maximal grip strength is measured for both hands.
Range of movement
Time frame: The change from baseline universal goniometer score at week 4
Universal goniometers is used. Wrist flexion, wrist extension, radial and ulnar deviation scores (for both hands) are measured.
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Mehmet SÖNMEZ, MSc study director
Erzurum Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented Fruit ninja game in people with Cerebral Palsy, run by Erzurum Technical University at 1 site 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 1 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Manual Dexterity (time frame: The change from baseline box and block test score at week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.