Writing DisorderKALIGO+NCT06858566
Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders : KALIGO+
A study testing Kaligo + score in people with Writing Disorder, run by Fondation Ildys at 1 site in France.
Trial summary
Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Writing Disorder
- What is being tested?
- Kaligo + score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2025to 24 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with writing difficulties (who may or may not be receiving care in this area)
- Age: 6 - 11 years
- Score > 1 standard deviation on the BHK deterioration score
Who cannot join
- Contraindication to the use of the tablet or virtual reality
- Moderate, severe or profound intellectual disability (Total Intelligence Quotient below 55 on an intellectual efficiency scale such as WISC-V or K-ABC-II).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation ILDYS
Brest, 29218
Manon LE GOFF, 0298028308, manon.legoff@ildys.org
Ludovic MIRAMAND
About this study
Official title: Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders: a Multiple Baseline Online SCED Study
Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Initial studies into the use of new technologies (tablets, virtual reality headsets) have shown that they can help children learn to write. Attractive to children, these interfaces make it possible to apply new paradigms (e.g. enrichment of feedback [sonification], variation of writing media) that have proved effective, mainly with children with 'typical' development. The Kaligo+ solution is based on the latest scientific advances to offer an innovative approach to learning to write, particularly for children with significant difficulties in this area. This study proposes to test the benefits of the Kaligo+ solution on 15 children with writing difficulties.
The main objective of this pilot study is to demonstrate improved writing performance following use of the Kaligo+ solution in children aged 6 to 11 with writing difficulties, using a Single Case Experimental Design (SCED) methodology.
- Conditions
- Writing Disorder
- Being tested
- Kaligo + score
- Keywords
- learning to write, writing disorders, SCED study, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaligo + scoreOther
The Kaligo + Score will be taken twice a week during baseline and intervention and once a week during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Children with handwriting difficulties | Experimental | Not described Receives: Other: Kaligo + score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +
Static parameters: density, height, width and length Kinematic parameters: Time (in air and on paper), speed, number of speed inversion, median frequency of the speed, jerk and acceleration.
Pressure: Median, 60th percentile, median frequency of the pressure change. The score is normalized between 0 (worst) and 1 (best).
Measured: This assessment will be carried out twice a week up to 19 weeks during the baseline and intervention and once a week up to 1 month after the interventiona
Secondary outcomes (13)
Assessing the ecological impact and its generalisation
Movement Assessment Battery for Children | Second Edition (M-ABC-II). Questionnaire to assess motor skills in everyday situations, comprising 3 parts: part A "movement in a static and/or predictable environment", part B "movement in a dynamic and/or non-static environment", part C "non-motor factors that can affect movement". A raw score is obtained for each of these parts, as well as a total motricity score (A + B).
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Handwriting Proficiency Screening Questionnaire for Children (HPSQ-C). Questionnaire to assess motor skills in everyday situations, comprising 3 parts: part A "movement in a static and/or predictable environment", part B "movement in a dynamic and/or non-static environment", part C "non-motor factors that can affect movement". A raw score is obtained for each of these parts, as well as a total motricity score (A + B).
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention
Assessing the ecological impact and its generalisation
Concise Assessment Scale for Children's Handwriting (BHK). In the BHK [Brave Handwriting Kindergarten], the child is asked to copy a text for 5 minutes. Blind double scoring is used (the scorer does not know when the child has copied the text). A degradation score is calculated: the higher the score, the more "degraded" the quality of the child's handwriting. The standardized score is taken into account for inclusion (to situate the child's performance in relation to his class), while the raw score is taken into account over the course of the intervention (allowing comparison of the subject with himself). Psychometric qualities are documented in the test manual.
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
NEPSY-II is the only single measure that allows clinicians to create tailored assessments across six domains, specific to a child's situation SUBTESTS - ORIENTATION SUBTEST - VISUO-MOTOR PRECISION SUBTEST - INHIBITION SUBTEST - FACE RECOGNITION
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Purdue Pegboard Test (PPT). Test of manual dexterity and bimanual coordination. The child must place rods in holes on a board as quickly as possible, using the dominant hand, the non-dominant hand, then both hands simultaneously. In a final condition ("assembly"), the child must place a rod in one of the holes, then a washer, a tube and another washer, using both hands alternately. Raw scores (number of correctly placed and assembled pieces) are taken into account.
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Written Language Analytical Battery (BALE). In the BALE [Batterie Analytique du Langage Ecrit, Analytic test of the written language], the child is asked to write (under dictation) simple, complex and frequent irregular words from the French language, and to read regular and frequent irregular words. For the purposes of this study, only raw scores will be taken into account, in order to compare the subject with himself.
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
- Evaluate the maintenance of performance over time after the end of the intervention
Evolution of the Kaligo + score. Kaligo + Score: This composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure).
Measured: This assessment will be carried out at the end of the intervention and every week for a month.
Assessing the specific nature of the intervention
Evolution of performance on an untrained task. It will be demonstrated by the absence of as great an improvement in the control variable (face recognition task) compared with the improvement recorded in the primary endpoint
Measured: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention
Assessing satisfaction with the intervention for the child and his or her family
The CSQ 8 is a short customer satisfaction questionnaire. The CSQ8 is the benchmark questionnaire for assessing satisfaction among parents, children and teenagers.
Measured: during the last visit, 1 month after intervention
Assessing satisfaction with the intervention for the child and his or her family
10-point visual analogue scale to be completed by the child.
Measured: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
Mobile Application Rating Scale (MARS). This validated questionnaire makes it possible to assess the quality of mobile healthcare applications in a way that is transparent for healthcare professionals and patients alike.
Measured: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
System Usability Scale (SUS). This questionnaire is currently the most widely used in the scientific community for measuring user satisfaction with a product, interactive system or service.
Measured: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
Carrying out qualitative interviews with families and professionals
Measured: during the last visit, , 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start21 Mar 2025
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Writing DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design - SCED
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle PONS BECMEUR, MP/PhD, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858566
- Sponsor's protocol ID
- RI2022_008
- Acronym
- KALIGO+
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 28 Mar 2025
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders: a Multiple Baseline Online SCED Study
- ClinicalTrials.gov ID
- NCT06858566
- Acronym / sponsor ID
- KALIGO+ / RI2022_008
- Conditions
- Writing Disorder
- Keywords
- learning to write, writing disorders, SCED study, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 5 Mar 2025 (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.
Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Initial studies into the use of new technologies (tablets, virtual reality headsets) have shown that they can help children learn to write. Attractive to children, these interfaces make it possible to apply new paradigms (e.g. enrichment of feedback [sonification], variation of writing media) that have proved effective, mainly with children with 'typical' development. The Kaligo+ solution is based on the latest scientific advances to offer an innovative approach to learning to write, particularly for children with significant difficulties in this area. This study proposes to test the benefits of the Kaligo+ solution on 15 children with writing difficulties.
The main objective of this pilot study is to demonstrate improved writing performance following use of the Kaligo+ solution in children aged 6 to 11 with writing difficulties, using a Single Case Experimental Design (SCED) methodology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design - SCED
| Arm | Type | Receives |
|---|---|---|
| Children with handwriting difficulties | Experimental | Other: Kaligo + score |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with writing difficulties (who may or may not be receiving care in this area)
- Age: 6 - 11 years
- Score > 1 standard deviation on the BHK deterioration score
Key exclusion criteria (2 listed)
- Contraindication to the use of the tablet or virtual reality
- Moderate, severe or profound intellectual disability (Total Intelligence Quotient below 55 on an intellectual efficiency scale such as WISC-V or K-ABC-II).
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 |
|---|---|---|
| Kaligo + scoreThe Kaligo + Score will be taken twice a week during baseline and intervention and once a week during follow-up. | Other | Children with handwriting difficulties |
Primary outcome
Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo +
Time frame: This assessment will be carried out twice a week up to 19 weeks during the baseline and intervention and once a week up to 1 month after the interventiona
Static parameters: density, height, width and length Kinematic parameters: Time (in air and on paper), speed, number of speed inversion, median frequency of the speed, jerk and acceleration. Pressure: Median, 60th percentile, median frequency of the pressure change. The score is normalized between 0 (worst) and 1 (best).
13 secondary outcomes
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
Assessing the ecological impact and its generalisation
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention.
- Evaluate the maintenance of performance over time after the end of the intervention
Time frame: This assessment will be carried out at the end of the intervention and every week for a month.
Assessing the specific nature of the intervention
Time frame: This assessment will be conducted during the first week of the baseline, in the 10th week of the intervention, and once more one month after the intervention
Assessing satisfaction with the intervention for the child and his or her family
Time frame: during the last visit, 1 month after intervention
Assessing satisfaction with the intervention for the child and his or her family
Time frame: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
Time frame: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
Time frame: during the last visit, 1 month after intervention
Assessing the acceptability and usability of the solution for families and professionals
Time frame: during the last visit, , 1 month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Christelle PONS BECMEUR, MP/PhD principal investigator
Fondation Ildys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaligo + score in people with Writing Disorder, run by Fondation Ildys at 1 site 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon LE GOFF (0298028308 ext. +33, manon.legoff@ildys.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score brings together a set of parameters defining writing efficiency (static, kinematic and pressure) : Kaligo + (time frame: This assessment will be carried out twice a week up to 19 weeks during the baseline and intervention and once a week up to 1 month after the interventiona). 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 28 Mar 2025.