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Performance Analysis in Down Syndrome on Mobile Phone

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Down Syndrome Group 1
Down Syndrome Group 2
Typical Development Group 1
Typical Development Group 2
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Down Syndrome focused on measuring Down syndrome, motor skills, physiotherapy, mobile telephone, exposure to virtual reality therapy

Eligibility Criteria

11 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of DS;
  • ability to perform a gripping movement to hold the mobile phone with one of the hands.

Exclusion Criteria:

  • presence of comorbidities such as autism or other associated genetic alterations;
  • functional disability that impedes the execution of the task or failure of task comprehension after five attempts carried out during the familiarization phase.

Sites / Locations

  • Associacao de Pais e Amigos dos Excepcionais de Amparo (APAE)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Down Syndrome Group 1

Down Syndrome Group 2

Typical Development Group 1

Typical Development Group 2

Arm Description

Acquisition and retention phase on maze A, transfer on maze B and C.

Acquisition and retention phase on maze C, transfer on maze A and B.

Control group. Acquisition and retention phase on maze A, transfer on maze B and C.

Control group. Acquisition and retention phase on maze C, transfer on maze A and B.

Outcomes

Primary Outcome Measures

Improvement of performance
that individuals with DS would be able to adapt to the virtual task using the mobile phone and improve performance with practice in acquisition, as well as maintain the performance in transfer tasks, namely, to change the maze.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2016
Last Updated
April 8, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02882698
Brief Title
Performance Analysis in Down Syndrome on Mobile Phone
Official Title
Performance Analysis in Down Syndrome Through a Maze Game on Mobile Phone
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The game Marble Maze Classic® will be used, in which the participants have to move the mobile phone to conduct a virtual marble through a maze design. The investigators will evaluate 100 individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2 using a maze design totally opposite to group 1.
Detailed Description
The game Marble Maze Classic® will be used, in which the participants have to move the mobile phone to conduct a virtual marble through a maze design. The investigators will evaluate 100 individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2 using a maze design totally opposite to group 1. Participants from both SD and TD will be divided into two subgroups: Group 1 (n = 50, consisting of 25 participants in TD and 25 participants in SD) and Group 2 (n = 50, consisting 25 participants in TD and 25 participants in SD), with the design of the maze for group 2 totally opposite to that of group 1 in all stages of the experiment. The use of opposite mazes is necessary to verify that the sequence of movements of the maze path does not influence performance. To maintain the characteristics of random sampling, where each participant has an equal chance to participate in the groups, The investigators used simple probabilistic random sampling, by conducting the drawing on paper. PROCEDURES Individuals will be positioned comfortably in a chair set according to the size necessary, as well as a footrest, so as to stay properly positioned to enable the execution of the task. Before starting the task, the functioning of the game will be verbally explained, along with a demonstration made by the examiner. The examiner will state that the goal of the game is to get the marble to the end of the maze in the shortest possible time through movements up, down and sideways (supination and pronation of the forearm, flexion and extension of the wrist and fingers). Participants will perform all attempts with the dominant hand (except in intermanual transfer phase) and this task will be repeated several times according to the design of the experiment. In each experiment phase (acquisition, retention and transfer) the execution time will be noted of the entire path from the beginning of the maze until the end point, and in each phase this path has to be performed by a specific amount of repetitions. To try to match the difficulty of the task, the mazes are customized with paths that require eight basic movements for the virtual marble to reach the target, with two movements of forearm pronation, two supination, two wrist flexion and two extension. In the design of the learning protocol, the participants have to perform 30 repetitions of the maze task for the acquisition phase with the dominant hand, each group with their own maze. After these 30 repetitions, there was a 5-minute rest period in which the participant is not in contact with the task. Then, 5 repetitions will be performed in the retention phase with the same maze acquisition. For the transfer phase, the participants will perform 15 repetitions divided into 3 blocks of 5 attempts using different maze designs: Transfer A: a maze with the path in a different layout to the acquisition (five repetitions); Transfer B: the same acquisition maze, however carried out with non-dominant hand (five repetitions); Transfer 3: the same acquisition maze with the start-end point of the path reversed (five repetitions).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, motor skills, physiotherapy, mobile telephone, exposure to virtual reality therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Down Syndrome Group 1
Arm Type
Experimental
Arm Description
Acquisition and retention phase on maze A, transfer on maze B and C.
Arm Title
Down Syndrome Group 2
Arm Type
Experimental
Arm Description
Acquisition and retention phase on maze C, transfer on maze A and B.
Arm Title
Typical Development Group 1
Arm Type
Active Comparator
Arm Description
Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
Arm Title
Typical Development Group 2
Arm Type
Active Comparator
Arm Description
Control group. Acquisition and retention phase on maze C, transfer on maze A and B.
Intervention Type
Behavioral
Intervention Name(s)
Down Syndrome Group 1
Intervention Description
Acquisition and retention phase on maze A, transfer on maze B and C.
Intervention Type
Behavioral
Intervention Name(s)
Down Syndrome Group 2
Intervention Description
Acquisition and retention phase on maze C, transfer on maze A and B.
Intervention Type
Behavioral
Intervention Name(s)
Typical Development Group 1
Intervention Description
Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
Intervention Type
Behavioral
Intervention Name(s)
Typical Development Group 2
Intervention Description
Control group. Acquisition and retention phase on maze C, transfer on maze A and B.
Primary Outcome Measure Information:
Title
Improvement of performance
Description
that individuals with DS would be able to adapt to the virtual task using the mobile phone and improve performance with practice in acquisition, as well as maintain the performance in transfer tasks, namely, to change the maze.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of DS; ability to perform a gripping movement to hold the mobile phone with one of the hands. Exclusion Criteria: presence of comorbidities such as autism or other associated genetic alterations; functional disability that impedes the execution of the task or failure of task comprehension after five attempts carried out during the familiarization phase.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos BM Monteiro, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associacao de Pais e Amigos dos Excepcionais de Amparo (APAE)
City
Amparo
State/Province
Sao Paulo
ZIP/Postal Code
13905-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Performance Analysis in Down Syndrome on Mobile Phone

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