StrokeNCT06363279
Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation.
A study testing Conducting questionnaires in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Conducting questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Apr 2024to Oct 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects (> 18 years)
- Speak and understand French;
- Be able to give consent in paper or electronic format.
- Have had a single stroke;
- Have been out of hospital for at least 1 month.
Who cannot join
- Severe comprehension problems ;
- Inability to complete the questionnaire;
- Severe comprehension problems, prior to or following the stroke, preventing planned assessments.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Clinique Universitaires Saint-Luc
Brussels, Woluwé-Saint-Lambert, 1200
Thierry Lejeune, MD, PhD, +3227641648, thierry.lejeune@saintluc.uclouvain.be
Mathilde Van Durme, +3227641675, mathilde.vandurme@saintluc.uclouvain.be
About this study
Official title: Validation of the French Translation of the Affinity for Technology Interaction (ATI) Scale Questionnaire and Assessment of the Predisposition of Healthy Adults and Stroke Survivors to Use Technological Tools in Rehabilitation.
Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations, but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation.
The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study.
Read the detailed description
The primary objective of this cross-sectional study is to validate the French translation of the "Affinity for Technology Interaction" questionnaire in the general adult population and in an adult population that has suffered a stroke.
The secondary objective is to assess the propensity of these populations to use technological tools in everyday life and in rehabilitation.
The experiment is a cross-sectional study (online and paper survey). Subjects will be recruited in two ways: 1) via the Cliniques universitaires Saint-Luc; 2) via posters/flyers in paper and digital formats, the Internet (social networks), public places (university, etc.), acquaintances of the participants and of the research team, and via colleagues of the doctors/physiotherapists (samples of convenience and "snowballing"). Posters and publications on social networks will include information about the experiment and a link to the online questionnaire.
People who want to take part in the online survey will have to click on the link to be directed to the questionnaire on REDCap. Once they have given their consent electronically, i.e. by ticking 'yes' to 'I agree to take part in this study of my own free will', the questionnaire will appear and participants will be able to complete it (this will take approximately 5-10 minutes). Once they have completed the questionnaire, their participation in the study will be terminated. The questionnaire will be available online for a period of 12 months.
For people who wish to take part in the paper survey, after signing the information and consent documents, they will complete the paper version of the questionnaire with the assistance of an investigator. Once the questionnaire has been completed, their participation in the study will be terminated.
Selection criteria for subjects to be included in the experiment (all randomly selected subjects, all evaluable subjects, etc.).
- Healthy subjects: The healthy subjects included in the study will be volunteers recruited either through the Saint-Luc University Hospitals or through social networks, but also in public places (university), as well as through fellow physiotherapists and doctors. This study will be offered in several French-speaking countries (France, Canada, Belgium).
- People who have had a stroke: Stroke survivors enrolled in the study will be volunteers recruited either through the Saint-Luc University Hospitals Physical Medicine and Rehabilitation Department or through social networks and public places.
Precise statement of the main data to be evaluated during the experiment. The questionnaire (see appendix) is divided into 4 main sections: general information; French version of the ATI questionnaire; face validity and perceived usefulness; predisposition to use new technologies.
- General information: Questions on age, gender, postal code, country, socio-professional status and level of education. These data will be used to describe the sample studied (descriptive statistics) and to obtain the information needed to determine the factors associated with the ATI questionnaire score in multiple linear regression analyses. For post-stroke subjects, the questionnaire will be completed with information on the date of stroke, its functional classification, Rankin score and MOCA.
- French version of the ATI questionnaire: Questionnaire consisting of 9 items designed to assess the affinity for interaction with technological systems (such as mobile phones, computers, television, etc.). The response options for each item are in the form of a Likert scale ranging from "strongly disagree" (= 1) to "strongly agree" (= 6). A total score including the 9 items is then calculated to obtain the subject's score.
- Face validity and perceived usefulness: Five statements designed to assess the face validity and perceived usefulness of the questionnaire to respondents. The response options for each statement are in the form of a Likert scale ranging from 'strongly disagree' to 'strongly agree'.
- Predisposition to use technology: Questionnaire to assess predisposition to use new technologies in general and specifically in telerehabilitation. This questionnaire includes questions about the rehabilitation that the subjects are currently undergoing (type, frequency, investment and difficulties of access), as well as their propensity to use new tools (in rehabilitation and in daily life).
Expected duration of subjects' participation. The duration of participation includes only the time needed to complete the questionnaire. Without a break, we estimate that it will take about 10 minutes to complete the questionnaire. After that, participation in the study is over.
Data analysis methods including missing, unused or erroneous data. REDCap software will be used to conduct the surveys. REDCap is a statistical survey and online form creation software. It allows questionnaires to be published on the web or on smartphones to collect data. The software allows anonymous participation and an unlimited number of participants and questions. We can choose the start and end dates for the survey, as well as a server location for secure data storage. Thanks to this software, data collection will take place in real time and we will be able to monitor the results.
We will also be able to obtain the results of the survey in the form of statistics or graphs (e.g. number of responses per question) at any time. The survey results will be exported anonymously and securely in various formats (Excel, CSV, PDF, etc.) for processing and analysis in statistical software.
The data collected via the paper version (mainly for stroke patients) and REDCap will be imported into Excel and analysed using SPSS and R. The face validity, perceived usefulness and other aspects such as the ergonomics of the questionnaire will be assessed via the statements at the end of the questionnaire and the time taken to complete the questionnaire. We will also assess the reliability of the questionnaire by calculating its internal consistency (Cronbach Alpha) and its dimensionality by calculating the number of dimensions (exploratory factorial analysis).
Multiple linear regression analyses will also be carried out to assess the association between certain variables (e.g. age) and the score on the ATI questionnaire. Results are presented as coefficients with their 95% confidence intervals. All p-values are two-tailed and the significance level is set at p = 0.05.
- Conditions
- Stroke
- Being tested
- Conducting questionnaires
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conducting questionnairesOther
The questionnaires will be administered online or in person.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires on predisposition to the use of technology | Other | The questionnaire is divided into 4 main sections:
* General information: Questions on age, gender, postal code, country, socio-professional status and level of education.
* ATI questionnaire in French: Questionnaire consisting of 9 items to assess affinity for interaction with technological systems (such as mobile phones, computers, television, etc.).
* Face validity and perceived usefulness: Five statements designed to assess the face validity and perceived usefulness of the questionnaire to respondents. The response options for each statement are in the form of a Likert scale ranging from 'strongly disagree' to 'strongly agree'.
* Predisposition to use technology: Questionnaire to assess predisposition to use new technologies in general and specifically in telerehabilitation. Receives: Other: Conducting questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATI - affinity technology interaction scale
Evaluation scale in the form of a self-questionnaire to assess a person's affinity with technological communication tools.
French version of the ATI questionnaire: Questionnaire consisting of 9 items designed to assess the affinity for interaction with technological systems (such as mobile phones, computers, television, etc.). The response options for each item are in the form of a Likert scale ranging from "strongly disagree" (= 1) to "strongly agree" (= 6). A total score including the 9 items is then calculated to obtain the subject's score.
Measured: Baseline
Secondary outcomes (1)
Scale for assessing a person's readiness to use technological tools as part of their rehabilitation
Self-questionnaire concerning people's habits in relation to the use of technological tools, both overall and more specifically in terms of healthcare.
Predisposition to use technology: Questionnaire to assess predisposition to use new technologies in general and specifically in telerehabilitation. This questionnaire includes questions about the rehabilitation that the subjects are currently undergoing (type, frequency, investment and difficulties of access), as well as their propensity to use new tools (in rehabilitation and in daily life).
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start4 Apr 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lejeune Thierry, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363279
- Sponsor's protocol ID
- 2024/24JAN/044
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 2 May 2024
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Translation of the Affinity for Technology Interaction (ATI) Scale Questionnaire and Assessment of the Predisposition of Healthy Adults and Stroke Survivors to Use Technological Tools in Rehabilitation.
- ClinicalTrials.gov ID
- NCT06363279
- Acronym / sponsor ID
- 2024/24JAN/044
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Apr 2024 (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.
Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations, but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation.
The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study.
Detailed description
The primary objective of this cross-sectional study is to validate the French translation of the "Affinity for Technology Interaction" questionnaire in the general adult population and in an adult population that has suffered a stroke.
The secondary objective is to assess the propensity of these populations to use technological tools in everyday life and in rehabilitation.
The experiment is a cross-sectional study (online and paper survey). Subjects will be recruited in two ways: 1) via the Cliniques universitaires Saint-Luc; 2) via posters/flyers in paper and digital formats, the Internet (social networks), public places (university, etc.), acquaintances of the participants and of the research team, and via colleagues of the doctors/physiotherapists (samples of convenience and "snowballing"). Posters and publications on social networks will include information about the experiment and a link to the online questionnaire.
People who want to take part in the online survey will have to click on the link to be directed to the questionnaire on REDCap. Once they have given their consent electronically, i.e. by ticking 'yes' to 'I agree to take part in this study of my own free will', the questionnaire will appear and participants will be able to complete it (this will take approximately 5-10 minutes). Once they have completed the questionnaire, their participation in the study will be terminated. The questionnaire will be available online for a period of 12 months.
For people who wish to take part in the paper survey, after signing the information and consent documents, they will complete the paper version of the questionnaire with the assistance of an investigator. Once the questionnaire has been completed, their participation in the study will be terminated.
Selection criteria for subjects to be included in the experiment (all randomly selected subjects, all evaluable subjects, etc.).
- Healthy subjects: The healthy subjects included in the study will be volunteers recruited either through the Saint-Luc University Hospitals or through social networks, but also in public places (university), as well as through fellow physiotherapists and doctors. This study will be offered in several French-speaking countries (France, Canada, Belgium).
- People who have had a stroke: Stroke survivors enrolled in the study will be volunteers recruited either through the Saint-Luc University Hospitals Physical Medicine and Rehabilitation Department or through social networks and public places.
Precise statement of the main data to be evaluated during the experiment. The questionnaire (see appendix) is divided into 4 main sections: general information; French version of the ATI questionnaire; face validity and perceived usefulness; predisposition to use new technologies.
- General information: Questions on age, gender, postal code, country, socio-professional status and level of education. These data will be used to describe the sample studied (descriptive statistics) and to obtain the information needed to determine the factors associated with the ATI questionnaire score in multiple linear regression analyses. For post-stroke subjects, the questionnaire will be completed with information on the date of stroke, its functional classification, Rankin score and MOCA.
- French version of the ATI questionnaire: Questionnaire consisting of 9 items designed to assess the affinity for interaction with technological systems (such as mobile phones, computers, television, etc.). The response options for each item are in the form of a Likert scale ranging from "strongly disagree" (= 1) to "strongly agree" (= 6). A total score including the 9 items is then calculated to obtain the subject's score.
- Face validity and perceived usefulness: Five statements designed to assess the face validity and perceived usefulness of the questionnaire to respondents. The response options for each statement are in the form of a Likert scale ranging from 'strongly disagree' to 'strongly agree'.
- Predisposition to use technology: Questionnaire to assess predisposition to use new technologies in general and specifically in telerehabilitation. This questionnaire includes questions about the rehabilitation that the subjects are currently undergoing (type, frequency, investment and difficulties of access), as well as their propensity to use new tools (in rehabilitation and in daily life).
Expected duration of subjects' participation. The duration of participation includes only the time needed to complete the questionnaire. Without a break, we estimate that it will take about 10 minutes to complete the questionnaire. After that, participation in the study is over.
Data analysis methods including missing, unused or erroneous data. REDCap software will be used to conduct the surveys. REDCap is a statistical survey and online form creation software. It allows questionnaires to be published on the web or on smartphones to collect data. The software allows anonymous participation and an unlimited number of participants and questions. We can choose the start and end dates for the survey, as well as a server location for secure data storage. Thanks to this software, data collection will take place in real time and we will be able to monitor the results.
We will also be able to obtain the results of the survey in the form of statistics or graphs (e.g. number of responses per question) at any time. The survey results will be exported anonymously and securely in various formats (Excel, CSV, PDF, etc.) for processing and analysis in statistical software.
The data collected via the paper version (mainly for stroke patients) and REDCap will be imported into Excel and analysed using SPSS and R. The face validity, perceived usefulness and other aspects such as the ergonomics of the questionnaire will be assessed via the statements at the end of the questionnaire and the time taken to complete the questionnaire. We will also assess the reliability of the questionnaire by calculating its internal consistency (Cronbach Alpha) and its dimensionality by calculating the number of dimensions (exploratory factorial analysis).
Multiple linear regression analyses will also be carried out to assess the association between certain variables (e.g. age) and the score on the ATI questionnaire. Results are presented as coefficients with their 95% confidence intervals. All p-values are two-tailed and the significance level is set at p = 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires on predisposition to the use of technology | Other | Other: Conducting questionnairesThe questionnaire is divided into 4 main sections: * General information: Questions on age, gender, postal code, country, socio-professional status and level of education. * ATI questionnaire in French: Questionnaire consisting of 9 items to assess affinity for interaction with technological systems (such as mobile phones, computers, television, etc.). * Face validity and perceived usefulness: Five statements designed to assess the face validity and perceived usefulness of the questionnaire to respondents. The response options for each statement are in the form of a Likert scale ranging from 'strongly disagree' to 'strongly agree'. * Predisposition to use technology: Questionnaire to assess predisposition to use new technologies in general and specifically in telerehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (> 18 years)
- Speak and understand French;
- Be able to give consent in paper or electronic format.
- Have had a single stroke;
- Have been out of hospital for at least 1 month.
Key exclusion criteria (3 listed)
- Severe comprehension problems ;
- Inability to complete the questionnaire;
- Severe comprehension problems, prior to or following the stroke, preventing planned assessments.
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 |
|---|---|---|
| Conducting questionnairesThe questionnaires will be administered online or in person. | Other | Questionnaires on predisposition to the use of technology |
Primary outcome
ATI - affinity technology interaction scale
Time frame: Baseline
Evaluation scale in the form of a self-questionnaire to assess a person's affinity with technological communication tools. French version of the ATI questionnaire: Questionnaire consisting of 9 items designed to assess the affinity for interaction with technological systems (such as mobile phones, computers, television, etc.). The response options for each item are in the form of a Likert scale ranging from "strongly disagree" (= 1) to "strongly agree" (= 6). A total score including the 9 items is then calculated to obtain the subject's score.
1 secondary outcome
Scale for assessing a person's readiness to use technological tools as part of their rehabilitation
Time frame: Basline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
Lejeune Thierry principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conducting questionnaires in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 May 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lejeune Thierry (027641648, thierry.lejeune@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATI - affinity technology interaction scale (time frame: Baseline). 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 2 May 2024.