Evaluation of Different Visual Keyboard Organizations on People With Complex Sensorimotor Disabilities (SK4All)

July 15, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Evaluate of Different Visual Keyboard Organizations on People With Complex Sensorimotor Disabilities

comparison of different visual keyboard configurations

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Garches, France, 92380
        • CHU Raymond Poincaré - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm with virtual keyboard
Arm with virtual keyboard: 16 days for each participant
Other: Keyboard
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SAMUEL POUPLIN, PhD, PFNT DEPARTMENT, Raymon Pincaré Hospital - APHP
  • Study Director: Mathieu THEBAUD, Laboratoire d'Assistances Technologiques, CMRRF Kerpape

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP240703
  • 2024-A01067-40 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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