Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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28 August 2017 |
Main ID: |
ISRCTN16603570 |
Date of registration:
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11/01/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Useability of the robot ZORA in pediatric rehabilitation
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Scientific title:
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Useability of a humanoid robot to increase the motivation to perform physical activity in typical developing children and hospitalized children in neutropenia |
Date of first enrolment:
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01/10/2015 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN16603570 |
Study type:
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Interventional |
Study design:
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Single-centre randomised cross-over study (Treatment)
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Pieter
Meyns |
Address:
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De Pintelaan 185
9000
Gent
Belgium |
Telephone:
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Email:
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Affiliation:
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Name:
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Pieter
Meyns |
Address:
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De Pintelaan 185
9000
Gent
Belgium |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children with cancer 1. 3 to 15 years old 2. Hospitalized at the pediatric cancer ward of the Ghent University Hospital 3. In neutropenia (i.e. low concentration of neutrophils in the blood)
Children without cancer 1. 4 to 13 years old 2. In an elementary school in Flanders, Belgium (BS De Vierklaver, Temse)
Exclusion criteria: 1. Insufficient knowledge of the Dutch language 2. Does not understand the instructions 3. Unable to perform the movements 4. No signed informed consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Childhood cancer with neutropenia (i.e. low concentration of neutrophils in the blood). Cancer
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Intervention(s)
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The protocol of the study comprises 2 parts:
Part 1 includes about 90 healthy typical children from the elementary school “De Vierklaver” in Temse, Belgium. Per grade (from kindergarten until the sixth year), about 10 children will be recruited at random. During physical education class every child will perform sets of exercises individually in four conditions:
Condition A consisted of an exercise set demonstrated by a human (therapist). Condition B was similar to condition A but with music added. Condition C consisted of an exercise set demonstrated by the humanoid robot. Condition D was similar to condition C but with music added
The sets of exercises are similar between conditions. In order to avoid a learning effect and prevent monotony, the sequence of movements was different in every condition. Each condition will last about 1-2 minutes. The sets of exercises and music are age-appropriate. After each condition the child will be asked whether they would want to perform the exercise again, and using a visual analogue scale they are asked how much fun they had. After all conditions they will be asked to order the conditions from the most fun to the least fun. The total testing time for one individual is estimated at 15 minutes. From the results it will be determined whether the different conditions (robot versus human & music versus no music) showed an effect on the motivation to perform the sets of exercises.
Part 2 of the study takes place at the University hospital Ghent. Maximum 30 children with an oncological disorder in the same age range, which suffer from neutropenia, will be asked to perform the same exercise sets in the same conditions (the level of difficulty will be adjusted to the patient’s abilities). The same outcome parameters will be measured as in part 1. During the rehabilitation of these children, the humanoid robot will be present as well (for children to get used to the robot). After one week the same exercise sets and conditions will
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Primary Outcome(s)
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Motivation, using Again Again table immediately after each exercise session. Three different aspects if motivation were measured: 1.1. How many times does the participants want to repeat the exercise 1.2. How much fun did they experience 1.3. Compared to the other exercises, where do they rank this exercise 2. Degree of fun experienced, assessed using the Smileyometer immediately after each exercise session. The Smileyometer is a visual analogue scale based on a 1 to 5 Likert scale using smileys developed for children 3. Most fun exercise session, assessed using the Funsorter once all exercise sessions were completed. Each child was asked to rank the conditions (A, B, C, D) from “least fun” (at the left of the grid) to “most fun” (at the right of the grid) on an empty grid
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Secondary ID(s)
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2015/0888
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Source(s) of Monetary Support
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Agentschap voor Innovatie door Wetenschap en Technologie
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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