GesturesNCT03387748
Cognitive Skills and Iconic Gestures
A study testing Gesture elicitation in people with Gestures, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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? Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gestures
- What is being tested?
- Gesture elicitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Mar 2018to 1 Oct 2021
- 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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Moderate Intellectual disability
- Down syndrome
Who cannot join
- neurodegenerative disorder
- non-corrected severe hearing impairment
- non-corrected severe visual impairment
- active knowledge of a sign language or manual signing system
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
KULeuven
Leuven, Flanders
Katholieke Universiteit Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Role of Semantic Processing and Visuospatial Skills in Production of Iconic Gestures
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?
Read the detailed description
Individuals with language difficulties (e.g., vocabulary or forming sentences) can find it difficult to communicate and express their thoughts. Speech-language therapists sometimes encourage individuals with language difficulties to use hand gestures. By using gestures these individuals may find it easier to express their thoughts and their communication partners may find it easier to comprehend them. The researchers aim to answer the question: which skills are needed to produce highly comprehensible gestures? The answers to this question can inspire future language therapy for individuals with language difficulties.
Task1. Participants sees 30 items from the Boston Naming Task one by one. The researcher explains that she can not see the screen. When an image appears, the examiner asks the participant to describe the item without speaking, but by using hand gestures. These gesture versions are recorded on video. The researcher indicates which gesture strategy the participant used with each executed gesture (i.e., sketch, shape, object, or deictic). In addition, 200 adults with a typical development assess the intelligibility of each gesture. The recordings are presented one by one in a random order. The evaluators must write down what concept the person depicts on the video. By adding the correct responses per participant, each participant receives a skill score. This skill score is related to the individual results of cognitive testing.
Task2. Participants watch a cartoon. They tell the story to the researcher who "has never seen the cartoon and does not know what is happening". Participants do not receive instructions on the use of gestures. This storytelling task is recorded on video. The researchers will write this down and note which gestures are being produced. The videos are used to calculate two variables: the ratio of the number of gestures to words, and the ratio of gestures that are replacements of speech to all gestures (both speech replacement and complementary to speech). These variables are related to the results of the cognitive tests.
Task3. The researcher starts a 1-on-1 interview (10 minutes) with the participant. This conversation partly proceeds according to a semi-structured script: a few questions have been drawn up in advance. Each question or comment contains two content words that make a gesture possible. During half of the scripted questions, the researcher will not use any gesture. During the other half, the researcher will produce the two gestures. As with a semi-structured interview, the researcher ensures a natural conversation. The conversations are recorded on video. The researcher transcribes the interviews and indicates whether the participant takes over the gestures of the researcher. Each time a script gesture is presented, the examiner indicates whether the participant has responded by applying the spoken word and / or the gesture. By involving the cognitive test results, it can be analyzed whether people with higher semantic processing and higher visual-spatial skills take over from others more often than those with weaker semantic processing skills and weaker visual-spatial skills.
- Conditions
- Gestures
- Being tested
- Gesture elicitation
- Medical subject headings
- Gestures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gesture elicitationBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Gesture elicitation | Experimental | Observation: hand gesture elicitation task Receives: Behavioral: Gesture elicitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: One observation per participant, 2 years to collect data for all participants
Secondary outcomes (2)
Gesture rate
Rate of iconic gestures per word during narrative task
Measured: One testing per participant, over period of 2 years for all participants
Gesture strategy
Rate of iconic gesture strategies: proportion of deictic gestures, proportion of shaping gestures, proportion of handling gestures, and proportion of drawing gestures
Measured: One testing per participant, over period of 2 years for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Mar 2018
- Primary completion1 Jul 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GesturesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-factorial, cross-sectional study (with control group)
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387748
- Sponsor's protocol ID
- S61109
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2017
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Semantic Processing and Visuospatial Skills in Production of Iconic Gestures
- ClinicalTrials.gov ID
- NCT03387748
- Acronym / sponsor ID
- S61109
- Conditions
- Gestures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 2 Jan 2018 (actual)
- 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.
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?
Detailed description
Individuals with language difficulties (e.g., vocabulary or forming sentences) can find it difficult to communicate and express their thoughts. Speech-language therapists sometimes encourage individuals with language difficulties to use hand gestures. By using gestures these individuals may find it easier to express their thoughts and their communication partners may find it easier to comprehend them. The researchers aim to answer the question: which skills are needed to produce highly comprehensible gestures? The answers to this question can inspire future language therapy for individuals with language difficulties.
Task1. Participants sees 30 items from the Boston Naming Task one by one. The researcher explains that she can not see the screen. When an image appears, the examiner asks the participant to describe the item without speaking, but by using hand gestures. These gesture versions are recorded on video. The researcher indicates which gesture strategy the participant used with each executed gesture (i.e., sketch, shape, object, or deictic). In addition, 200 adults with a typical development assess the intelligibility of each gesture. The recordings are presented one by one in a random order. The evaluators must write down what concept the person depicts on the video. By adding the correct responses per participant, each participant receives a skill score. This skill score is related to the individual results of cognitive testing.
Task2. Participants watch a cartoon. They tell the story to the researcher who "has never seen the cartoon and does not know what is happening". Participants do not receive instructions on the use of gestures. This storytelling task is recorded on video. The researchers will write this down and note which gestures are being produced. The videos are used to calculate two variables: the ratio of the number of gestures to words, and the ratio of gestures that are replacements of speech to all gestures (both speech replacement and complementary to speech). These variables are related to the results of the cognitive tests.
Task3. The researcher starts a 1-on-1 interview (10 minutes) with the participant. This conversation partly proceeds according to a semi-structured script: a few questions have been drawn up in advance. Each question or comment contains two content words that make a gesture possible. During half of the scripted questions, the researcher will not use any gesture. During the other half, the researcher will produce the two gestures. As with a semi-structured interview, the researcher ensures a natural conversation. The conversations are recorded on video. The researcher transcribes the interviews and indicates whether the participant takes over the gestures of the researcher. Each time a script gesture is presented, the examiner indicates whether the participant has responded by applying the spoken word and / or the gesture. By involving the cognitive test results, it can be analyzed whether people with higher semantic processing and higher visual-spatial skills take over from others more often than those with weaker semantic processing skills and weaker visual-spatial skills.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-factorial, cross-sectional study (with control group)
| Arm | Type | Receives |
|---|---|---|
| Gesture elicitation | Experimental | Behavioral: Gesture elicitationObservation: hand gesture elicitation task |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Moderate Intellectual disability
- Down syndrome
Key exclusion criteria (4 listed)
- neurodegenerative disorder
- non-corrected severe hearing impairment
- non-corrected severe visual impairment
- active knowledge of a sign language or manual signing system
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 |
|---|---|---|
| Gesture elicitation* 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. | Behavioural | Gesture elicitation |
Primary outcome
Gesture iconicity
Time frame: One observation per participant, 2 years to collect data for all participants
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) .
2 secondary outcomes
Gesture rate
Time frame: One testing per participant, over period of 2 years for all participants
Gesture strategy
Time frame: One testing per participant, over period of 2 years for all participants
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 4 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gesture elicitation in people with Gestures, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 4 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 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Gesture iconicity (time frame: One observation per participant, 2 years to collect data for all participants). 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 4 Apr 2023.