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Down SyndromeNCT05332912

Assessing Malleability of Spatial Abilities in Down Syndrome

A study testing Spatial Ability Experience in people with Down Syndrome, run by University of Alabama, Tuscaloosa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Based on available literature and our own preliminary research, the researchers have concluded that persons with Down syndrome (DS) exhibit difficulties in utilizing the specific spatial abilities of mental rotation and perspective taking and performing complex spatial tasks such as wayfinding and environmental… Read more about this study

Who is it for?
Ages 4 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Down Syndrome
What is being tested?
Spatial Ability Experience
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 31 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 4 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Typically Developing Children ages 4.0 years to 9.0 years
  • Individuals with Down Syndrome ages 10.0 - 25.0
  • Verbal Comprehension Ability at 4.0 years or above

Who cannot join

  • Inability to follow verbal instructions
  • Inability of use tablet computer

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama, Tuscaloosa

    Tuscaloosa, Alabama, 35405

Other trials in United States

About this study

Official title: Assessing the Malleability of Spatial Abilities in Individuals With Down Syndrome

Based on available literature and our own preliminary research, the researchers have concluded that persons with Down syndrome (DS) exhibit difficulties in utilizing the specific spatial abilities of mental rotation and perspective taking and performing complex spatial tasks such as wayfinding and environmental learning. A weakness in spatial abilities may have many direct applications to daily life, ranging from activities such as tying shoes to using hand tools and navigating the environment. Spatial abilities also serve as a cognitive foundation for many other complex skills such as solving mathematical problems and using spatial language for giving and receiving directions. Moreover, spatial abilities are used in a variety of specialty jobs such as grocery stocking, packaging, and assembling, which are among the most commonly reported jobs for adults with DS. Hence, a new focus on spatial ability and its modifiability in persons with DS is clearly warranted. The primary goal of the research proposed in this application is to evaluate the malleability of mental rotation and perspective taking in people with DS through providing intentional experience with numerous spatial activities. Two groups of participants will be tested over the course of the project: adolescents and young adults with DS and typically developing (TD) children. Following an initial evaluation of performance on the two abilities, participants will receive up to eight sessions of spatial activity experience utilizing puzzle construction, block building, and computer search tasks. Following the experience sessions, spatial abilities of participants will be re-evaluated. These data will be used to investigate two specific aims. First, the researchers investigate whether spatial abilities of persons with DS can be modified by experience with spatial activities. Second, the researchers investigate whether the degree of modification observed for persons with DS can reduce performance differences between them and TD children. The researchers also consider whether performance on the PPVT, Raven's matrices, and Chronological Age are associated with any benefits from spatial ability experience.

Read the detailed description

Participants will take part in a study designed to facilitate the development of two spatial abilities: Mental Rotation and Visual Perspective Taking. Mental rotation reflects the ability to mentally manipulate a small object without physically rotating it. Perspective taking reflects the ability to imagine what a large environment would look like from a different position. Both abilities are important for engaging in everyday spatial activities such as navigating the environment without getting lost. The researchers have constructed four tasks to provide experience with these two abilities over the course of approximately four months. There will be an initial assessment (one week), followed by eight weeks of experiences using four different spatial ability games, a second assessment, eight more weeks of experience, and then a third assessment.

The initial assessment will include four measures:

Ravens 2 Matrices: The Ravens 2 Matrices is a 60 item measure of nonverbal ability. The subtest measures a participant's ability to solve problems, identify relationships, and complete visual analogies without testing language skill. The examiner shows the participant pictures or abstract designs that follow a pattern, with one element missing. The participant is instructed to point to a picture that will complete the pattern. Participants will be matched on raw score performance. Completing the subtest should take less than 15 minutes for most participants. We will use Age-Equivalent scores as our measure of performance. The score can range from 48 to 239 months and are standardized scores reflecting participant's ability level at the time of testing.

PPVT-4: The PPVT - 4 is a norm-referenced test for measuring receptive vocabulary of children and adults. The test is administered individually. Each item consists of four colored pictures that serve as response choices on each page. For each item, the examiner says a word and the examinee selects the picture option that best represents the word's meaning. The test is normed for 2 years, 6 months to 90 years. Average time to administer the test is 10 - 15 minutes. We will use Age-Equivalents scores for the PPVT. Age-equivalent scores can range from 30 to 218 months and are standardized scores.

Mental Rotation Assessment - On each trial, participants will be presented a shape (e.g., a block letter L) in the center of a computer screen that completes one of two silhouettes presented in rectangles at the bottom of the same screen. The open area in one rectangle is the mirror image of the open area in the second rectangle. The shape in the center of the screen will fit one of the rectangles when horizontal. The shape can be rotated from horizontal by 0, 45, 90, 135, 180, 225, 270, or 315 degrees. Participants respond by touching the rectangle into which the shape will fit once oriented properly (using touchscreen technology).

Number of correct responses (excluding 0 rotation trials) are counted. Scores can range from 0 to 18. To directly compare performance on Motel Rotation with performance on Perspective Taking, percent of total available points are used on the analyses.

Perspective Taking - Participants will be seated at a table with four chairs and four different objects (e.g., street lamp, mailbox, stop sign, traffic signal) representing each location on the corner of a city block in front of each chair. A stuffed animal is placed behind each object. One experimenter walks around the table stopping at various locations around the table (12 different locations). At each location, the participant is told that the experimenter is taking a picture from that location and he/she is asked to look at four pictures. The task is to select the picture that the experimenter has just taken. The four pictures consist of the participant's point of view, a mirror image of the participant's point of view, the experimenter's (correct) point of view, and a mirror image of the experimenter's point of view. This task will take 5 - 10 minutes. Participants are given 3 points for selecting the experimenter's (correct) perspective, 2 points for selecting the mirror image of the experimenter's perspective, 1 point for selecting the view opposite their own perspective, and 0 points for selecting their own perspective. Total points in this task could range from 0 to 36.

Percent of total available points earned on this task is used as the measure of perspective taking to allow comparison with mental rotation performance.

Assessments 2 and 3 will include only Mental Rotation and Perspective Taking Assessments.

Spatial Ability Experience will include two tasks of Object manipulation and two Large Environment Experiences.

Object Manipulation Experience: Two categories of tasks will be used to provide object manipulation experience: LEGO Block Play and Puzzle Construction. One task will be used in each spatial ability experience, with tasks alternating between sessions.

LEGO Block Play: Participants and experimenter will each have 20 multi-colored and multi-shaped connecting blocks. During play, the participant and experimenter will alternate creating structures and copying what the other has created during the 15-minute interval. No specific corrective feedback will be given during the experience, although participants will be asked if the construction matches the model. Object manipulation rather than accuracy is the basis of the experience. Participants will be allowed to take as long as needed to complete their copy of each structure.

Puzzle Construction: The researchers will select puzzles that include 4, 8, 12, 16, or 20 puzzle pieces. All puzzles will have pieces that need to be rotated to fit the puzzle board to provide the necessary object manipulation experience. The puzzle board will also include the outline of the shapes of the pieces. Hence, participants will need to match the outline of the piece with the rotated actual piece to efficiently complete the puzzle. Touching each piece with a finger will rotate the piece and removing the finger will stop the rotation. Participants will be given five puzzles to complete during the experience session. The participant will be given 3 minutes to complete each puzzle. If the participant completes the puzzle, the next larger size puzzle will be used for the participant's next opportunity. If the participant fails to complete the puzzle, the size of the puzzle will be reduced by one level.

Large Environment Experience: Two categories of tasks using a large-scale virtual environment will be used to provide object manipulation experience: Hide and Seek and Wayfinding. One task will be used in each spatial ability experience, with tasks alternating between sessions.

Hide and Seek Video Game: Several settings are used to limit boredom with the task. For example, participants are shown a panoramic view in a living room. In the center of the picture is a stuffed animal who was identified as the seeker in the game. They are then shown a view of what the seeker could see - which includes four different color boxes. They are told another animal (e.g., dog) is hiding behind one of the boxes. Then they are shown what the dog could see looking back at the seeker. They are asked to identify where the dog is hiding based on what the dog could see. If incorrect, they are asked to try again. They are given four different animals to located during each session the task is used.

Wayfinding Video Game: Children will be exposed to a scene using Google street view and asked to search for specific targets that can be scene along the path. In order to complete the task, the participant will need to be able to identify the targets from different perspectives.

Children who are assigned to the Control condition will receive the spatial ability experiences following an eight-week delay after the initial assessment.

Conditions
Down Syndrome
Being tested
Spatial Ability Experience
Medical subject headings
Down Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spatial Ability ExperienceBehavioural

    Participants will engage in puzzle construction, block play, visual search, hide and seek

Study groups in NCT05332912
Study groupRoleWhat they receive
ImmediateExperimentalParticipants will receive 16 weeks of spatial ability experience.
Receives: Behavioral: Spatial Ability Experience
DelayedPlacebo comparatorParticipants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.
Receives: Behavioral: Spatial Ability Experience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mental Rotation Ability at 8 Weeks

    The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.

    Measured: Following 8 weeks of experience training.

  2. Change in Mental Rotation Ability at 16 Weeks

    The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 3) Assessment scores.

    Measured: Following 16 weeks of experience training.

  3. Change in Perspective Taking Ability at 8 Weeks

    Measure Description: Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. . Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.

    Measured: Following 8 weeks of experience training.

  4. Change in Perspective Taking Ability at 16 Weeks

    Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 16 Week (Time 3) Assessment scores.

    Measured: Following 16 weeks of experience training.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start1 Apr 2021
  3. Primary completion10 Aug 2024
  4. Study completion31 Mar 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Typically developing children will be compared to adolescents/young adults with Down syndrome (groups matched on non-verbal ability). A delayed start condition (verbal experience instead of spatial ability experience) of eight weeks will be used for 1/2 of participants in each group.
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332912
Sponsor's protocol ID
19-08-2644
Status last verified
Sep 2025
First submitted
2 Apr 2022
Last updated
14 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual Participant Data (IPD) will be available upon request after the study is completed, data has been analyzed, and the primary data has been published or within 5 years of study completion if data has not been published. Requests can be made to the PI.

Questions about this trial

What is this clinical trial studying?

A study testing Spatial Ability Experience in people with Down Syndrome, run by University of Alabama, Tuscaloosa at 1 site in United States.

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 3 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 14 Oct 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mental Rotation Ability at 8 Weeks (time frame: Following 8 weeks of experience training.). The study lists 4 primary outcomes in all. 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 14 Oct 2025.

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