NCT04759677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

February 10, 2021

Last Update Submit

May 22, 2021

Conditions

Keywords

energy expenditureexercise intensityvideo games

Outcome Measures

Primary Outcomes (3)

  • Energy consumption (MET) Exercise Intensity

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

    up to 2 days

  • Activity counts

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

    up to 2 days

  • Active time

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

    up to 2 days

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

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.

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pınar Kaya Ciddi

    İstanbul Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Orofessor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 18, 2021

Study Start

February 1, 2021

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations