Performance Analysis in Down Syndrome on Mobile Phone

NCT02882698 | Completed

• 1 other identifier: 341/1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Down syndrome; motor skills; physiotherapy; mobile telephone; exposure to virtual reality therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 months

Study Arms (4)

Down Syndrome Group 1

EXPERIMENTAL

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

Behavioral: Down Syndrome Group 1

Down Syndrome Group 2

EXPERIMENTAL

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

Behavioral: Down Syndrome Group 2

Typical Development Group 1

ACTIVE COMPARATOR

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

Behavioral: Typical Development Group 1

Typical Development Group 2

ACTIVE COMPARATOR

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

Behavioral: Typical Development Group 2

Interventions

Down Syndrome Group 1 BEHAVIORAL

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

Down Syndrome Group 1

Down Syndrome Group 2 BEHAVIORAL

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

Down Syndrome Group 2

Typical Development Group 1 BEHAVIORAL

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

Typical Development Group 1

Typical Development Group 2 BEHAVIORAL

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

Typical Development Group 2

Eligibility Criteria

• Age: 11 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Amparo, São Paulo, 13905-010, Brazil

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Carlos BM Monteiro, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 30, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

BR (1)