- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876480
Evaluation of Different Visual Keyboard Organizations on People With Complex Sensorimotor Disabilities (SK4All)
Evaluate of Different Visual Keyboard Organizations on People With Complex Sensorimotor Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Information and communication technologies (ICT) occupy an increasingly important place in our daily lives (CREDOC, 2021). Similarly, for the general population faced with these information and communication technologies, people with sensorimotor disabilities want and can claim socio-professional integration, access to knowledge through school integration facilitated by the Internet, access to leisure activities and social participation (Folan et al., 2015) (Picard, 2007) (Angelo et al., 2007) (Cornes & Bochel, 1987). Consequently, information and communication technologies are essential for people with sensorimotor disabilities and restoring this communication is fundamental.
Regarding access to digital tools, people with sensorimotor disabilities have difficulty accessing the pointing device (moving the mouse cursor, but also the various clicks) and input text (accessing the standard keyboard). Many assistive devices exist depending on the disabilities and abilities of the people, but also on their life habits, environmental constraints and expected uses of the computer tool (LoPresti and Brienza, 2004) (DeVries et al., 1998) (Yu-Luen Chen et al., 2003) (Y.-L. Chen et al., 2003) (Biard et al., 2011).
However, for people with complex sensorimotor disabilities, when few functional movements are possible, scanning access on a visual keyboard is preferred. At this stage, the movement of the mouse cursor, mouse clicks and text input are grouped under the same interface (visual keyboard) controlled by one or two switches. The visual keyboard presents the letters, the arrows for the direction of the mouse cursor and the different clicks (Figure 1).
In aims to increase people's text input speed, several studies have shown that the addition of linguistic prediction modules (of words or characters) would, in theory, make input text faster (Schadle & Poirier, 2004) (Trnka et al., 2007):
Word prediction (or completion) enables words or completions to be proposed in order to reduce the number of characters to be entered. By reducing the entry of certains characters, the text input speed should theoretically be increased. In fact, this is not necessarily the case (Raynal & Badr, 2022) (Pouplin et al., 2014).
Character prediction rearranges the layout of characters after each input, according to the probability of each one being selected. In this way, the most likely character becomes the one that can be accessed most quickly, with the least scanning. It has been shown that in the case of a pointing keyboard, this prediction does not satisfy users any more than word prediction (MacKenzie, 2008). Nevertheless, for scanning keyboards, which we are interested in here, even though there are few studies with real users, we can see that in some cases, character prediction seems interesting (Pouplin et al., 2014). Nevertheless, the main drawback of character prediction is that it results to a dynamic display of the keyboard. Indeed, the integration of character prediction seems to take place in much the same way from one study to the next, meaning a reorganization of the character set and therefore of the entire display. This prevents any memorization of the character layout for the user, and thus a certain amount of learning.
Therefore, we propose to integrate character prediction while keeping the display as static as possible.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Garches, France, 92380
- CHU Raymond Poincaré - APHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- People with complex sensorimotor disabilities who are unable to communicate in standard written and digital form.
- Persons aged 18 or over
- Ability to read and write French
- Patient who own and use IT tool
- Patient who has used or used a virtual scanning keyboard to access IT Tools
- Health insurance beneficiary or rightful dependent
- Patient who has signed an informed and written consent. or
- Adult patient under guardianship who has signed an informed and written consent with the assistance of their guardian.
- Person agreeing to the terms of the protocol (home visits by the investigator).
Exclusion Criteria:
- Having visual impairments preventing the use of the IT Tools
- Patient under State Medical Aid (except in cases of exemption from affiliation).
- Persons deprived of liberty
- Pregnant or breastfeeding women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm with virtual keyboard
Arm with virtual keyboard: 16 days for each participant
|
Day 0 : Collection of the general data required for the study, installation of the computer device including the LifeCompanion software with the different scanning keyboards configurations and organizations.
Day 0 to Day 8 : write, in copy, a text using each of the virtual keyboard configurations.
Day 8 : copying a text proposed by the investigator of identical difficulty for each condition, for a duration of 15 minutes, per experimental condition.
This copying exercise, with the recording of measurements, will be done for each experimental condition.
Day 8 to Day 16 : write a copy of a text of his/her choice for 10 minutes, using each of the virtual keyboard configurations.
Day 16 : in a text-entry evaluation situation, copying a text proposed by the investigator, of identical difficulty for each condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Text input speed evaluation
Time Frame: at 16 days
|
To evaluate the influence of different visual keyboard organizations on text input speed in people with complex sensorimotor disabilities. Evaluation criteria: Text input speed (characters/minutes). |
at 16 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the influence of visual keyboard organizations on fatigue
Time Frame: at 16 days
|
To evaluate the influence of different visual keyboard organizations on fatigue in people with complex sensorimotor disabilities. Evaluation criteria: Self-assessment of fatigue (Visual Analog Scale (VAS)). |
at 16 days
|
|
Evaluation of usability efficiency
Time Frame: at 16 days
|
To evaluate the influence of different visual keyboard organizations on the usability efficiency of the system by people with complex sensorimotor disabilities. Evaluation criteria: Input validity (percentage), System use strategy efficiency score (percentage). |
at 16 days
|
|
Self-assessment of satisfaction
Time Frame: at 16 days
|
To evaluaSelf-aste the influence of different visual keyboard organizations on text input system satisfaction in people with complex sensorimotor impairments. Self-assessment of satisfaction (Visual Analogue Scale (VAS)). |
at 16 days
|
|
Oculometric data evaluation
Time Frame: at 16 days
|
To evaluate the influence of different visual keyboard organizations on the distance covered by users' gaze. Evaluation criteria: Oculometric data (raw value). |
at 16 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: SAMUEL POUPLIN, PhD, PFNT DEPARTMENT, Raymon Pincaré Hospital - APHP
- Study Director: Mathieu THEBAUD, Laboratoire d'Assistances Technologiques, CMRRF Kerpape
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP240703
- 2024-A01067-40 (Registry Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.