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CompletedNCT04759677Updated May 25, 2021

Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy

An interventional study of Exercise with active video games in Cerebral Palsy, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by Medipol University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • energy expenditure
  • exercise intensity
  • video games
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 20 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • 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.

    Other: Exercise with active video games

  • 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.

    Other: Exercise with active video games

Interventions

  • OtherExercise with active video games

    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.

06

What researchers measure

Primary outcomes

  1. Energy consumption (MET) Exercise Intensity

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

    Time frame: up to 2 days

  2. Activity counts

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

    Time frame: up to 2 days

  3. Active time

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

    Time frame: up to 2 days

07

Study locations

1 site
  • Medipol University
    İstanbul, Beykoz 34810, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04759677
Lead sponsor
Medipol University
Responsible party
Pınar Ciddi (Assistant Orofessor, Medipol University) — Principal investigator
First posted
Feb 18, 2021
Start date
Feb 1, 2021
Primary completion
Apr 1, 2021
Completion
May 1, 2021
Last update
May 25, 2021

Study contacts

Pınar Kaya Ciddi
principal investigator · İstanbul Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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