Clinical trial NCT03883815: The Effect of Video-based Game Therapy on Treatment Intensity in Children With Cerebral Palsy
Official title: The Effect of Video Based Game Therapy on Activity Amount and Energy Consumption in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
neurodevelopmental therapy
active video games
treatment intensity
energy consumption
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Having a diagnosis of cerebral palsy by a qualified physician, between the ages of 6-18 and continuing ambulations,
2. Functional to Gross Motor Function Classification System be between levels I-III,
3. To be cooperative during the evaluation and treatment sessions,
4. Individuals do not have a history of genetic and / or neurological disease other than cerebral palsy,
5. 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,
6. To be able to play the game with sufficient balance to be able to stand,
7. Have not played Nintendo Wii before,
8. There is no defect in the visual functions except breakage defect

Exclusion Criteria:

1. Passing muscle-tendon and bone operation less than 6 months ago,
2. have been exposed to any pharmacological agent to inhibit spasticity within 6 months,
3. have cognitive / mental problems that will interfere with communication with him / she will not understand working instructions,
4. Difficulty in visual functions except for fracture failure,
5. A history of genetic and / or neurological disease other than cerebral palsy,
6. The patient was negatively affected by physical activity and was diagnosed as having epileptic seizures.

Primary outcomes:
measure: energy consumption
timeFrame: 45 minutes
Secondary outcomes:
measure: number of activities
timeFrame: 45 minutes
measure: active time during session
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
state: Eyalet/Yerleşke
Study officials:
References: