Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy

May 22, 2021 updated by: Pınar Ciddi, Medipol University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beykoz
      • İstanbul, Beykoz, Turkey, 34810
        • Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: the situation where the accelerometer is placed on the wrist during active video games playing
In one session the accelerometer will place on the dominant wrist Individuals will instructed not to remove and instruct them to wear the device during the session.
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.
ACTIVE_COMPARATOR: the situation where the accelerometer is placed on the hip during active video games playing

In one session the accelerometer will place on a flexible belt by attaching to the hip area at the intersection of the dominant wrist and axillary line.

Individuals will instructed not to remove and instruct them to wear the device during the session.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2 days
Activity counts
Time Frame: up to 2 days
Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
up to 2 days
Active time
Time Frame: up to 2 days
Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pınar Kaya Ciddi, İstanbul Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (ACTUAL)

February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 22, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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