Cerebral PalsyNCT03883815
The Effect of Video-based Game Therapy on Treatment Intensity in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
In a recent review by Kolobe et al., It was reported that there was no study investigating the effects of treatment intensity on upper or lower extremity function in children with traumatic brain injury and cerebral palsy. 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?
- Active Video Games Therapy
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2017to 15 Nov 2018
- Phase
- Observational
- 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
Study population: Individuals with a diagnosis of Cerebral Palsy who had been undergoing physiotherapy for 2 days a week between the ages of 6 and 18 were included in the study.
Who may be able to join
- Having a diagnosis of cerebral palsy by a qualified physician, between the ages of 6-18 and continuing ambulations,
- Functional to Gross Motor Function Classification System be between levels I-III,
- To be cooperative during the evaluation and treatment sessions,
- Individuals do not have a history of genetic and / or neurological disease other than cerebral palsy,
- In terms of the movements of the upper extremities; Should be able to shoulder flexion up to 90 degrees, have enough functional hand ability to grasp the Nintendo Wii control, actively flex elbow and extension within the functional limits, lack of spasticity of the upper extremity muscles which may interfere with all these movements,
- To be able to play the game with sufficient balance to be able to stand,
- Have not played Nintendo Wii before,
- There is no defect in the visual functions except breakage defect
Who cannot join
- Passing muscle-tendon and bone operation less than 6 months ago,
- have been exposed to any pharmacological agent to inhibit spasticity within 6 months,
- have cognitive / mental problems that will interfere with communication with him / she will not understand working instructions,
- Difficulty in visual functions except for fracture failure,
- A history of genetic and / or neurological disease other than cerebral palsy,
- The patient was negatively affected by physical activity and was diagnosed as having epileptic seizures.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol University
Istanbul, Eyalet/Yerleşke, 34810
About this study
Official title: The Effect of Video Based Game Therapy on Activity Amount and Energy Consumption in Children With Cerebral Palsy
In a recent review by Kolobe et al., It was reported that there was no study investigating the effects of treatment intensity on upper or lower extremity function in children with traumatic brain injury and cerebral palsy. In other words, any study in this review reported no studies on the amount of effort or the number of repetitions at high or low intensity.
This indicates a clear gap in the literature related to density, which is a dosage variable for cerebral palsy.
Read more
It is difficult to determine and increase density without having strong, practical methods to measure density during rehabilitation.
Therefore, there is a clear need for alternative measurements to measure density.
As the alternative measurements, the number of repetitions, the duration of active time during the sessions are used.
Energy consumption seen as a useful tool for evaluating functional capacity may also reflect activity intensity by measuring the intensity of activity during the session.
Because the ability to perform an activity when interpreted; It is considered as an indicator of fatigue and endurance.
Children with cerebral palsy have decreased selective muscle control, abnormal muscle tone, imbalance between agonist and antagonist muscles, and abnormalities in balance due to inadequate balance reactions.
Due to all these reasons, cerebral palsy in children has been shown to have higher energy consumption during physical activities such as walking compared to healthy children.
Children with cerebral palsy usually have difficulty in regular participation in treatment and adaptation to traditional home exercise programs. Active video games are recommended for use in addition to neurodevelopmental therapy and, in particular, for home use, because of the potential for increasing treatment dosage.
Researchers focus on evidence in terms of exercise games, Some games on the market (Wii Sports tennis and boxing and Dance Dance Revolution) have achieved that the physical activity measured by the metabolic equivalent, which is necessary to perform the tasks in individuals with cerebral palsy, is associated with the level of moderate severity.
In this study, it is aimed to compare the treatment intensity, performance and balance parameters of the patients with cerebral palsy in a planned neurodevelopmental treatment session and active video games.
In this study, the effects of clinical type, age and functional level on treatment intensity, performance and balance parameters during these sessions will be investigated.
Hypothesis of the study In line with the needs of children with cerebral palsy, there is a difference in terms of treatment intensity, performance and balance parameters between a planned neurodevelopmental treatment session and active video games.
- Conditions
- Cerebral Palsy
- Being tested
- Active Video Games Therapy
- Keywords
- cerebral palsy, neurodevelopmental therapy, active video games, treatment intensity, energy consumption
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Video Games TherapyOther
Also called Neurodevelopmental therapy
Interventions were completed in 1-week periods, after 3 clinical visits. All individuals underwent both neurodevelopmental therapy and active video games therapy. Demographic data of individuals were recorded and muscle tone and gross motor functions were evaluated at the first visit. The games determined by the physiotherapist were explained and experienced by individuals. During the second visit, individuals played 4 games that were previously determined and experienced for about 45 minutes. On the last visit, individuals underwent neurodevelopmental therapy. During both treatment sessions, the accelerometer was fitted on a flexible belt by attaching it to the dominant wrist. Individuals were instructed not to remove the device during both treatment sessions.
One session individuals treated with exercises which weight transfer and postural reactions were facilitated.
Other session they played Nintendo Wii games in accordance with their current level and skills.
| Study group | Role | What they receive |
|---|---|---|
| Assesment treatment intensity | Assesment treatment intensity during neurodevelopmental therapy session and active video games therapy session Receives: Other: Active Video Games Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy consumption
data on energy consumption during sessions obtained as a result of accelerometer device (in Metabolic Equivalence)
Measured: 45 minutes
Secondary outcomes (2)
number of activities
data on acitivity numbers during sessions obtained as a result of accelerometer device (in counts)
Measured: 45 minutes
active time during session
data on active time during sessions obtained as a result of accelerometer device (in minutes)
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start15 Aug 2017
- Primary completion15 Aug 2018
- Study completion15 Nov 2018
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Ciddi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883815
- Sponsor's protocol ID
- 10840098-604.01.01-E.26936
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Based Game Therapy on Activity Amount and Energy Consumption in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03883815
- Acronym / sponsor ID
- 10840098-604.01.01-E.26936
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, neurodevelopmental therapy, active video games, treatment intensity, energy consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 21 Mar 2019 (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 a recent review by Kolobe et al., It was reported that there was no study investigating the effects of treatment intensity on upper or lower extremity function in children with traumatic brain injury and cerebral palsy. In other words, any study in this review reported no studies on the amount of effort or the number of repetitions at high or low intensity.
This indicates a clear gap in the literature related to density, which is a dosage variable for cerebral palsy.
It is difficult to determine and increase density without having strong, practical methods to measure density during rehabilitation.
Therefore, there is a clear need for alternative measurements to measure density.
As the alternative measurements, the number of repetitions, the duration of active time during the sessions are used.
Energy consumption seen as a useful tool for evaluating functional capacity may also reflect activity intensity by measuring the intensity of activity during the session.
Because the ability to perform an activity when interpreted; It is considered as an indicator of fatigue and endurance.
Children with cerebral palsy have decreased selective muscle control, abnormal muscle tone, imbalance between agonist and antagonist muscles, and abnormalities in balance due to inadequate balance reactions.
Due to all these reasons, cerebral palsy in children has been shown to have higher energy consumption during physical activities such as walking compared to healthy children.
Children with cerebral palsy usually have difficulty in regular participation in treatment and adaptation to traditional home exercise programs. Active video games are recommended for use in addition to neurodevelopmental therapy and, in particular, for home use, because of the potential for increasing treatment dosage.
Researchers focus on evidence in terms of exercise games, Some games on the market (Wii Sports tennis and boxing and Dance Dance Revolution) have achieved that the physical activity measured by the metabolic equivalent, which is necessary to perform the tasks in individuals with cerebral palsy, is associated with the level of moderate severity.
In this study, it is aimed to compare the treatment intensity, performance and balance parameters of the patients with cerebral palsy in a planned neurodevelopmental treatment session and active video games.
In this study, the effects of clinical type, age and functional level on treatment intensity, performance and balance parameters during these sessions will be investigated.
Hypothesis of the study In line with the needs of children with cerebral palsy, there is a difference in terms of treatment intensity, performance and balance parameters between a planned neurodevelopmental treatment session and active video games.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assesment treatment intensity | – | Other: Active Video Games TherapyAssesment treatment intensity during neurodevelopmental therapy session and active video games therapy session |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals with a diagnosis of Cerebral Palsy who had been undergoing physiotherapy for 2 days a week between the ages of 6 and 18 were included in the study.
Key inclusion criteria (8 listed)
- Having a diagnosis of cerebral palsy by a qualified physician, between the ages of 6-18 and continuing ambulations,
- Functional to Gross Motor Function Classification System be between levels I-III,
- To be cooperative during the evaluation and treatment sessions,
- Individuals do not have a history of genetic and / or neurological disease other than cerebral palsy,
- In terms of the movements of the upper extremities; Should be able to shoulder flexion up to 90 degrees, have enough functional hand ability to grasp the Nintendo Wii control, actively flex elbow and extension within the functional limits, lack of spasticity of the upper extremity muscles which may interfere with all these movements,
Key exclusion criteria (6 listed)
- Passing muscle-tendon and bone operation less than 6 months ago,
- have been exposed to any pharmacological agent to inhibit spasticity within 6 months,
- have cognitive / mental problems that will interfere with communication with him / she will not understand working instructions,
- Difficulty in visual functions except for fracture failure,
- A history of genetic and / or neurological disease other than cerebral palsy,
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 |
|---|---|---|
| Active Video Games TherapyAlso: Neurodevelopmental therapyInterventions were completed in 1-week periods, after 3 clinical visits. All individuals underwent both neurodevelopmental therapy and active video games therapy. Demographic data of individuals were recorded and muscle tone and gross motor functions were evaluated at the first visit. The games determined by the physiotherapist were explained and experienced by individuals. During the second visit, individuals played 4 games that were previously determined and experienced for about 45 minutes. On the last visit, individuals underwent neurodevelopmental therapy. During both treatment sessions, the accelerometer was fitted on a flexible belt by attaching it to the dominant wrist. Individuals were instructed not to remove the device during both treatment sessions. One session individuals treated with exercises which weight transfer and postural reactions were facilitated. Other session they played Nintendo Wii games in accordance with their current level and skills. | Other | Assesment treatment intensity |
Primary outcome
energy consumption
Time frame: 45 minutes
data on energy consumption during sessions obtained as a result of accelerometer device (in Metabolic Equivalence)
2 secondary outcomes
number of activities
Time frame: 45 minutes
active time during session
Time frame: 45 minutes
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 21 Mar 2019.
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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.
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?
An observational study of Cerebral Palsy, run by Medipol 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 8 inclusion and 6 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 21 Mar 2019. 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. 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?
energy consumption (time frame: 45 minutes). 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 21 Mar 2019.