CP (Cerebral Palsy)NCT05667792
Examination of the Effects of Video-Based Games on Balance, Trunk Proprioception, Motivation and Quality of Life in Individuals With Cerebral Palsy
A study testing Microsoft Kinect 360 and Pediatric Rehabilitation in people with CP (Cerebral Palsy), run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
In the study we planned, 42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 will be included in the adolescent group. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- CP (Cerebral Palsy)
- What is being tested?
- Microsoft Kinect 360 and Pediatric Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 22 Jul 2022
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Botulinum toxin administration in the last 6 months Having had any surgical operation in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal Üniversitesi
Antakya, Hatay, 31000
About this study
In the study we planned, 42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 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 20 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.
Read the detailed description
A total of 42 patients with cerebral palsy who agreed to participate in the study, 22 patients between the ages of 4-11 and 22 patients between the ages of 12-18, will be included. Parents of the patients will be informed about the study.
42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 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 20 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.
- Conditions
- CP (Cerebral Palsy)
- Being tested
- Microsoft Kinect 360, Pediatric Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsoft Kinect 360Device
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.
Pediatric RehabilitationOther
Bobath therapy
| Study group | Role | What they receive |
|---|---|---|
| Study Group- 4-11 age | Experimental | Not described Receives: Device: Microsoft Kinect 360; Other: Pediatric Rehabilitation |
| Control Group-4-11 age | Placebo comparator | Not described Receives: Other: Pediatric Rehabilitation |
| Study Group- 12-18 age | Experimental | Not described Receives: Device: Microsoft Kinect 360; Other: Pediatric Rehabilitation |
| Control Group-12-18 age | Placebo comparator | Not described Receives: Other: Pediatric Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: beginning and week 10
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
Measured: beginning and week 10
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.
Measured: beginning and week 10
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
Measured: beginning and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start5 May 2022
- Primary completion5 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CP (Cerebral Palsy)Studies 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, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkan Cicek, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667792
- Sponsor's protocol ID
- MustafaKU-PTIlkan
- Status last verified
- Mar 2024
- First submitted
- 1 Aug 2022
- Last updated
- 5 Mar 2024
- Results posted
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effects of Video-Based Games on Balance, Trunk Proprioception, Motivation and Quality of Life in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05667792
- Acronym / sponsor ID
- MustafaKU-PTIlkan
- Conditions
- CP (Cerebral Palsy)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 29 Dec 2022 (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.
In the study we planned, 42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 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 20 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 42 patients with cerebral palsy who agreed to participate in the study, 22 patients between the ages of 4-11 and 22 patients between the ages of 12-18, will be included. Parents of the patients will be informed about the study.
42 individuals diagnosed with cerebral palsy will be divided into 2 groups according to age groups. Individuals aged 4-11 will be included in the child group, and individuals aged 12-18 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 20 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Group- 4-11 age | Experimental | Device: Microsoft Kinect 360, Other: Pediatric Rehabilitation |
| Control Group-4-11 age | Placebo comparator | Other: Pediatric Rehabilitation |
| Study Group- 12-18 age | Experimental | Device: Microsoft Kinect 360, Other: Pediatric Rehabilitation |
| Control Group-12-18 age | Placebo comparator | Other: Pediatric Rehabilitation |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Botulinum toxin administration in the last 6 months Having had any surgical operation in the last 6 months
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 |
|---|---|---|
| Microsoft Kinect 360Balance 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. | Device | Study Group- 12-18 age, Study Group- 4-11 age |
| Pediatric RehabilitationBobath therapy | Other | Control Group-12-18 age, Control Group-4-11 age, Study Group- 12-18 age, Study Group- 4-11 age |
Primary outcome
One Leg Standing Test
Time frame: beginning and week 10
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
Time frame: beginning and week 10
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
Time frame: beginning and week 10
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
Time frame: beginning and week 10
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
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 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for CP (Cerebral Palsy)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microsoft Kinect 360 and Pediatric Rehabilitation in people with CP (Cerebral Palsy), run by Mustafa Kemal 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 1 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 5 Mar 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?
One Leg Standing Test (time frame: beginning and week 10). 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 5 Mar 2024.