The Effect of Video-based Game Therapy on Treatment Intensity in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Effect of Video Based Game Therapy on Activity Amount and Energy Consumption in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883815
• Other study ID #: 10840098-604.01.01-E.26936
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: November 15, 2018

Study information

• Verified date: March 2019
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Active Video Games 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.

Locations

Country	Name	City	State
Turkey	Medipol University	Istanbul	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy consumption	data on energy consumption during sessions obtained as a result of accelerometer device (in Metabolic Equivalence)	45 minutes
Secondary	number of activities	data on acitivity numbers during sessions obtained as a result of accelerometer device (in counts)	45 minutes
Secondary	active time during session	data on active time during sessions obtained as a result of accelerometer device (in minutes)	45 minutes