Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04759677 |
| Other study ID # |
E-10840098-772.02-2683 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Medipol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
