Down SyndromeNCT02882698
Performance Analysis in Down Syndrome on Mobile Phone
A study testing Down Syndrome Group 1, Down Syndrome Group 2 and Typical Development Group 1 in people with Down Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Down Syndrome Group 1, Down Syndrome Group 2 and Typical Development Group 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- diagnosis of DS;
- ability to perform a gripping movement to hold the mobile phone with one of the hands.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associacao de Pais e Amigos dos Excepcionais de Amparo (APAE)
Amparo, São Paulo, 13905-010
About this study
Official title: Performance Analysis in Down Syndrome Through a Maze Game on Mobile Phone
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.
Read the 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).
- Conditions
- Down Syndrome
- Being tested
- Down Syndrome Group 1, Down Syndrome Group 2, Typical Development Group 1, Typical Development Group 2
- Keywords
- Down syndrome, motor skills, physiotherapy, mobile telephone, exposure to virtual reality therapy
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Down Syndrome Group 1Behavioural
Acquisition and retention phase on maze A, transfer on maze B and C.
Down Syndrome Group 2Behavioural
Acquisition and retention phase on maze C, transfer on maze A and B.
Typical Development Group 1Behavioural
Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
Typical Development Group 2Behavioural
Control group. Acquisition and retention phase on maze C, transfer on maze A and B.
| Study group | Role | What they receive |
|---|---|---|
| Down Syndrome Group 1 | Experimental | Acquisition and retention phase on maze A, transfer on maze B and C. Receives: Behavioral: Down Syndrome Group 1 |
| Down Syndrome Group 2 | Experimental | Acquisition and retention phase on maze C, transfer on maze A and B. Receives: 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. Receives: 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. Receives: Behavioral: Typical Development Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882698
- Sponsor's protocol ID
- 341/1
- Status last verified
- Apr 2017
- First submitted
- 18 Aug 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Analysis in Down Syndrome Through a Maze Game on Mobile Phone
- ClinicalTrials.gov ID
- NCT02882698
- Acronym / sponsor ID
- 341/1
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, motor skills, physiotherapy, mobile telephone, exposure to virtual reality therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome Group 1 | Experimental | Behavioral: Down Syndrome Group 1Acquisition and retention phase on maze A, transfer on maze B and C. |
| Down Syndrome Group 2 | Experimental | Behavioral: Down Syndrome Group 2Acquisition and retention phase on maze C, transfer on maze A and B. |
| Typical Development Group 1 | Active comparator | Behavioral: Typical Development Group 1Control group. Acquisition and retention phase on maze A, transfer on maze B and C. |
| Typical Development Group 2 | Active comparator | Behavioral: Typical Development Group 2Control group. Acquisition and retention phase on maze C, transfer on maze A and B. |
Who may qualify
- Ages
- 11 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosis of DS;
- ability to perform a gripping movement to hold the mobile phone with one of the hands.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Down Syndrome Group 1Acquisition and retention phase on maze A, transfer on maze B and C. | Behavioural | Down Syndrome Group 1 |
| Down Syndrome Group 2Acquisition and retention phase on maze C, transfer on maze A and B. | Behavioural | Down Syndrome Group 2 |
| Typical Development Group 1Control group. Acquisition and retention phase on maze A, transfer on maze B and C. | Behavioural | Typical Development Group 1 |
| Typical Development Group 2Control group. Acquisition and retention phase on maze C, transfer on maze A and B. | Behavioural | Typical Development Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Down Syndrome Group 1, Down Syndrome Group 2 and Typical Development Group 1 in people with Down Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of performance (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.