Clinical trial NCT04759677: Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy
Official title: Energy Expenditure And Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy: Hip Versus Wrist Accelerometer Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: energy expenditure
exercise intensity
video games
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. During the training sessions, exercise intensity will be evaluated with the accelerometer.

The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. .

All 20 individuals with CP will participate in a total of 2 exercise sessions on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.

The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.

Exercise intensity will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions.

For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration.

Detailed description: More validation studies are needed to document the most appropriate place (wrist or waist) to capture limb movement and / or energy consumption (capturing) during physical activity in children with CP at different functional levels. Such information has the potential to guide interventions to improve daily activity throughout life, with potential implications for participation and quality of life.

The purpose of this study is to compare the energy consumption and exercise intensities obtained from an activity classifier obtained from a triaxial acceleration signal collected from the wrist and hip during active video games in children with ambulated Cerebral Palsy. Thus, it is thought that reaching the targeted physical activity intensity with active video games in individuals with CP in the clinic can be evaluated with an appropriate and accurate accelerometer placement.

Functional levels of individuals will be determined according to GMFCS. All 20 individuals with CP will participate in a total of 2 exercise sessions with on consecutive days with 45 minutes of active video games. In two exercise season individuals will play 4 games that were previously determined and experienced for about 45 minutes. During the training sessions, exercise intensity will be evaluated with the accelerometer.

The accelerometer will be placed on the dominant wrist of 20 individuals during one training session. The same 20 individuals will participate in the other exercise session and the accelerometer will be placed on the dominant side hip area of the individuals this time. Exercise intensity values obtained from 2 different training sessions will be compared.

Exercise intensity (energy consumption (MET), activity counts, active time during session) will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the interventions. After the measurements were over, the accelerometer data will be loaded on a personal computer and manipulated in ActiLife software version 6.13.3.

For both intervention sessions, a statistical comparison will made between groups in terms of energy consumption, activity counts, and active duration. Statistical analysis will be performed using SPSSc 22.00 package program. Number and percentage will be used for demographic data, mean ± standard deviation notation and descriptive data. In the dependent variables, inter-measurement changes will be evaluated with Wilcoxon test, inter-measurement changes in independent variables will be evaluated by Mann Whitney U test.

Eligibility criteria: Inclusion Criteria

* must be at I-III level according to the Gross Motor Function Classification System (GMFCS)
* must be able to cooperate during assessments and exercise sessions
* must have sufficient functional dexterity to grasp the Nintendo Wii remote control

Exclusion Criteria:

* having excessive upper extremity spasticity that can interfere with movements while playing
* playing Nintendo Wii before
* genetic or neurological disease other than CP diagnosis and epilepsy
* having had muscle-tendon and bone surgery less than 6 months ago
* use of any pharmacological agent to inhibit spasticity less than 6 months ago

Primary outcomes:
measure: Energy consumption (MET) Exercise Intensity
timeFrame: up to 2 days
measure: Activity counts
timeFrame: up to 2 days
measure: Active time
timeFrame: up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Medipol University
state: Beykoz
Study officials:
affiliation: İstanbul Medipol University
name: Pınar Kaya Ciddi
role: PRINCIPAL_INVESTIGATOR
References: