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Trial record 2 of 41 for:    Open Studies | "Down Syndrome"

Performance Analysis in Down Syndrome on Mobile Phone

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Carlos Bandeira de Mello Monteiro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02882698
First received: August 18, 2016
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Down Syndrome
Behavioral: Down Syndrome Group 1
Behavioral: Down Syndrome Group 2
Behavioral: Typical Development Group 1
Behavioral: Typical Development Group 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Performance Analysis in Down Syndrome Through a Maze Game on Mobile Phone

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Improvement of performance [ Time Frame: Up to 3 months ]
    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.


Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Down Syndrome Group 1
Acquisition and retention phase on maze A, transfer on maze B and C.
Behavioral: Down Syndrome Group 1
Acquisition and retention phase on maze A, transfer on maze B and C.
Experimental: Down Syndrome Group 2
Acquisition and retention phase on maze C, transfer on maze A and B.
Behavioral: Down Syndrome Group 2
Acquisition and retention phase on maze C, transfer on maze A and B.
Active Comparator: Typical Development Group 1
Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
Behavioral: Typical Development Group 1
Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
Active Comparator: Typical Development Group 2
Control group. Acquisition and retention phase on maze C, transfer on maze A and B.
Behavioral: Typical Development Group 2
Control group. Acquisition and retention phase on maze C, transfer on maze A and B.

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).
  Eligibility

Ages Eligible for Study:   11 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02882698

Contacts
Contact: Lilian DC Menezes +55(19)982707731 liliandelciello@hotmail.com

Locations
Brazil
Associacao de Pais e Amigos dos Excepcionais de Amparo (APAE) Not yet recruiting
Amparo, Sao Paulo, Brazil, 13905-010
Contact: Lilian EM Oliveira    +55 (19) 3807-2888    apaeamparo@uol.com.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Carlos BM Monteiro, Ph.D. University of Sao Paulo
  More Information

Responsible Party: Carlos Bandeira de Mello Monteiro, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02882698     History of Changes
Other Study ID Numbers: 341/1 
Study First Received: August 18, 2016
Last Updated: August 31, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Sao Paulo:
Down syndrome
motor skills
physiotherapy
mobile telephone
exposure to virtual reality therapy

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 27, 2017