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Completed

NCT Number: NCT04759677

Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise with active video games

Other

45-minute exercise in which individuals played pre-selected games from Nintendo Wii while keeping in mind their functional level, skills and needs. Four Nintendo Wii games were chosen: Island Cycling, Tilt Table Balance Board, Soccer Heading and Boxing. Each and every individual played these given four games consecutively in one session.

Primary outcomes

  1. Energy consumption (MET) Exercise Intensity

    Time frame: up to 2 days

    Energy consumption will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions

  2. Activity counts

    Time frame: up to 2 days

    Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions

  3. Active time

    Time frame: up to 2 days

    Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Energy Expenditure And Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy: Hip Versus Wrist Accelerometer Data

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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