- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883815
The Effect of Video-based Game Therapy on Treatment Intensity in Children With Cerebral Palsy
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Eyalet/Yerleşke
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Istanbul, Eyalet/Yerleşke, Turkey, 34810
- Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Assesment treatment intensity
Assesment treatment intensity during neurodevelopmental therapy session and active video games therapy session
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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energy consumption
Time Frame: 45 minutes
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data on energy consumption during sessions obtained as a result of accelerometer device (in Metabolic Equivalence)
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45 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of activities
Time Frame: 45 minutes
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data on acitivity numbers during sessions obtained as a result of accelerometer device (in counts)
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45 minutes
|
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active time during session
Time Frame: 45 minutes
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data on active time during sessions obtained as a result of accelerometer device (in minutes)
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45 minutes
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Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.26936
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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