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Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise with active video games
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring energy expenditure, exercise intensity, video games

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

the situation where the accelerometer is placed on the wrist during active video games playing

the situation where the accelerometer is placed on the hip during active video games playing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Energy consumption (MET) Exercise Intensity
Energy consumption will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Activity counts
Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Active time
Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions

Secondary Outcome Measures

Full Information

First Posted
February 10, 2021
Last Updated
May 22, 2021
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT04759677
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
energy expenditure, exercise intensity, video games

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the situation where the accelerometer is placed on the wrist during active video games playing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
the situation where the accelerometer is placed on the hip during active video games playing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise with active video games
Intervention Description
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 Outcome Measure Information:
Title
Energy consumption (MET) Exercise Intensity
Description
Energy consumption will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Time Frame
up to 2 days
Title
Activity counts
Description
Activity counts will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Time Frame
up to 2 days
Title
Active time
Description
Active time will be measured by an ActiGraph wGT3X-BT triaxial accelerometer during the exercise sessions
Time Frame
up to 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Kaya Ciddi
Organizational Affiliation
İstanbul Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medipol University
City
İstanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

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Exercise Intensity Of Interactive Video Gaming in Cerebral Palsy

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