NCT03387748

Brief Summary

In this study, cognitive skills will be identified that underlie the production of iconic gestures in individuals with language difficulties. Specifically, what is the role of nonverbal semantic processing and visuospatial skills in the use of iconic gestures?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

December 18, 2017

Last Update Submit

April 3, 2023

Conditions

Gestures

Outcome Measures

Primary Outcomes (1)

  • Gesture iconicity

    Likert scale score: understandability of each gesture that is performed. Range of each score: 1 (label: not understandable) to 5 (highly understandable) Summed score is used (range 30/150, with 150 highest performance) .

    One observation per participant, 2 years to collect data for all participants

Secondary Outcomes (2)

  • Gesture rate

    One testing per participant, over period of 2 years for all participants

  • Gesture strategy

    One testing per participant, over period of 2 years for all participants

Study Arms (1)

Gesture elicitation

EXPERIMENTAL

Observation: hand gesture elicitation task

Behavioral: Gesture elicitation

Interventions

Gesture elicitationBEHAVIORAL

* Participants are required to gesture with their hands (and not speaking) one by one 30 pictures from the Boston Naming Task which appear on a laptop screen. * Participants retell a cartoon to the researcher * The researcher initiates a 10-min spontaneous conversation. These three tasks are video-recorded.

Gesture elicitation

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Moderate Intellectual disability
  • Down syndrome

You may not qualify if:

  • neurodegenerative disorder
  • non-corrected severe hearing impairment
  • non-corrected severe visual impairment
  • active knowledge of a sign language or manual signing system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KULeuven

Leuven, Flanders, Belgium

Location

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Gestures

Condition Hierarchy (Ancestors)

KinesicsNonverbal CommunicationCommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: non-factorial, cross-sectional study (with control group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 2, 2018

Study Start

March 1, 2018

Primary Completion

July 1, 2020

Study Completion

October 1, 2021

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

BE(2)