DysorthographiaPredict4AllNCT04210661
Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating
A study testing prediction software with spell checker in people with Dysorthographia and Neurologic Disorder, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
Trial summary
The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user. The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Dysorthographia, Neurologic Disorder
- What is being tested?
- prediction software with spell checker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2020to 8 Mar 2022
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 6 and 25 years old For center 1
- patient with dysorthographia
- educational level greater than or equal to CE2
- A developmental level in reading on the Evalouette test (Evaleo battery) greater than or equal to CE1 For center 2
- Neurologic disorder impacting communication
Who cannot join
- Patient's refusal to participate in the study
- Persons under guardianship
- Pregnant women
- No affiliation to a social security scheme (beneficiary or beneficiary)
- Having visual disturbances preventing the use of the computer tool
Trial locations and contacts
2 sites in 1 country.
France2 sites
Raymond Poincaré hospital
Garches, 92380
CMRRF Kerpape
Ploemeur, 56270
About this study
Official title: Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating - Predict4All
The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user.
The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist).
Adapting the prediction to user errors should also allow it to be more relevant throughout the text input. This software efficiency must increase text input speed, Reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.
- Conditions
- Dysorthographia, Neurologic Disorder
- Being tested
- prediction software with spell checker
- Keywords
- word prediction, dysorthographia
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prediction software with spell checkerOther
test with prediction software with spell checker
| Study group | Role | What they receive |
|---|---|---|
| classic prediction software | Active comparator | test with classic precition software Receives: Other: prediction software with spell checker |
| prediction software with spell checker | Experimental | test with prediction software with spell checker Receives: Other: prediction software with spell checker |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of spelling errors
total of number of spelling errors during the test
Measured: 20 min
Secondary outcomes (6)
Text input speed
Text input speed in the test
Measured: 20 min
Prediction usage rate
number of times the prediction is used
Measured: 20 min
Keystrokes Saving Rate
measured by the percentage of input saved by word prediction versus a keyboard alone
Measured: 5 min
Attentional load
Likert Analog Visual Scale [0-10]
Measured: 1 min
Fatigue
Likert Analog Visual Scale [0-10]
Measured: 1 min
software Satisfaction
Likert Analog Visual Scale [0-10]
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start13 Feb 2020
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysorthographiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- interventionnal, prsopective, randomized, multicentric
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210661
- Sponsor's protocol ID
- 2019-A01882-55
- Acronym
- Predict4All
- Status last verified
- Feb 2022
- First submitted
- 23 Dec 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spelling Mistake Tolerant Word Prediction for Working, Writing and Communicating - Predict4All
- ClinicalTrials.gov ID
- NCT04210661
- Acronym / sponsor ID
- Predict4All / 2019-A01882-55
- Conditions
- Dysorthographia, Neurologic Disorder
- Keywords
- word prediction, dysorthographia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 26 Dec 2019 (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.
The main objective of the PREDICT4ALL project is to provide written communication in a computer, reducing the number of spelling errors for each user.
The effectiveness of written communication is defined in this study by the number of spelling errors for each user. Word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist).
Adapting the prediction to user errors should also allow it to be more relevant throughout the text input. This software efficiency must increase text input speed, Reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- interventionnal, prsopective, randomized, multicentric
| Arm | Type | Receives |
|---|---|---|
| classic prediction software | Active comparator | Other: prediction software with spell checkertest with classic precition software |
| prediction software with spell checker | Experimental | Other: prediction software with spell checkertest with prediction software with spell checker |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 6 and 25 years old For center 1
- patient with dysorthographia
- educational level greater than or equal to CE2
- A developmental level in reading on the Evalouette test (Evaleo battery) greater than or equal to CE1 For center 2
- Neurologic disorder impacting communication
Key exclusion criteria (5 listed)
- Patient's refusal to participate in the study
- Persons under guardianship
- Pregnant women
- No affiliation to a social security scheme (beneficiary or beneficiary)
- Having visual disturbances preventing the use of the computer tool
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 |
|---|---|---|
| prediction software with spell checkertest with prediction software with spell checker | Other | classic prediction software, prediction software with spell checker |
Primary outcome
number of spelling errors
Time frame: 20 min
total of number of spelling errors during the test
6 secondary outcomes
Text input speed
Time frame: 20 min
Prediction usage rate
Time frame: 20 min
Keystrokes Saving Rate
Time frame: 5 min
Attentional load
Time frame: 1 min
Fatigue
Time frame: 1 min
software Satisfaction
Time frame: 1 min
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 9 Mar 2022.
- Individual participant dataSharing planned: No
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 prediction software with spell checker in people with Dysorthographia and Neurologic Disorder, run by Centre d'Investigation Clinique et Technologique 805 at 2 sites in France.
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 5 inclusion and 5 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 9 Mar 2022. 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 France. 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?
number of spelling errors (time frame: 20 min). 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 9 Mar 2022.