ElderlySWADAPT4NCT05378828
Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD
A study testing Using anti-collision Sensors on electric wheelchairs and Use of an electric wheelchair without sensors in people with Elderly, run by Pôle Saint Hélier at 3 sites in France.
Trial summary
The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Using anti-collision Sensors on electric wheelchairs and Use of an electric wheelchair without sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Jul 2022to 26 Aug 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 60 years of age,
- Resident in an institution for the elderly or nursing home,
- with a electric wheelchair but expressing driving difficulties
- Having freely consented to participate in the study,
- In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and having given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient).
Who cannot join
- Impaired comprehension preventing the protocol from being carried out,
- Person in an emergency situation unable to give prior consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
Pôle Saint-Hélier
Rennes, Brittany Region, 35000
CCAS Saint-Etienne
Saint-Etienne, 42000
USLD Saint Etienne
Saint-Etienne, 42055
About this study
Official title: Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD
The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.
- Conditions
- Elderly
- Being tested
- Using anti-collision Sensors on electric wheelchairs, Use of an electric wheelchair without sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using anti-collision Sensors on electric wheelchairsDevice
use of anti-collision sensors on the electric wheelchair during 3 weeks
Use of an electric wheelchair without sensorsOther
Use of an electric wheelchair without sensors for 3 weeks before using anti-collision sensors then during 3 weeks after using the anti-collision sensors.
| Study group | Role | What they receive |
|---|---|---|
| Use of an electric wheelchair with or without sensors | Other | During 3 weeks, the electric weehlchair will not have sensors, then sensors will be put on the wheelchair for the next 3 weeks then removed for 3 other weeks. Receives: Device: Using anti-collision Sensors on electric wheelchairs; Other: Use of an electric wheelchair without sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD
Evaluation by using the under score of confidence of Wheelchair Skill Test questionnaire (WST-Q-T 5.1) during the period of use of the module and at the end.
The score goes from 0 to 56 (56 is the higher level of confidence).
Measured: Day 42
Secondary outcomes (5)
Driving habilities
Benefits of the sensors on ability and performance of tasks performed with the electric wheelchair by Wheelchair Skill Test questionnaire (WST-Q-T 5.1).
The score will go from 0 to 56 for each scale (performance and frequency), a high score will represent a good driving performance
Measured: Day 42 and Day 63
Distance traveled measured by sensors on the FRE
The distance will be measured in meters with a lap counter type.
Measured: Day 21, Day 42 and Day 63
Mesure of mental load related to wheelchair mobility
Mental load will be measured by the NASA-Task Load Index. It is in the form of six scales where the participant must assign a score between zero and one hundred to each of them, score indicating a growing level of intensity. Three dimensions relate to the demands imposed on the subject (mental, physical and temporal demands) and three to the interaction of a subject with the task (effort, frustration and performance).
Measured: Day 21, Day 42 and Day 63
Ease of Use Questionnaire
Satisfaction of using FRE by users will be mesured by the Ease of Use Questionnaire. He is composed of 27 questions, each question is valued between 0 to 7. a high score will represent a high satisfaction.
Measured: Day 42
Acceptability of anti-collision sensors by users
A acceptability questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) will be completed at day 42, with semi-directive interview
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start21 Jul 2022
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Why it stopped: difficulties encountered that were not highlighted in previous studies (traffic situations that made daily life difficult for users, need to rework the system)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, Centre Communal d'Action Sociale Saint-Etienne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378828
- Sponsor's protocol ID
- 2021-A03138-33
- Acronym
- SWADAPT4
- Status last verified
- Aug 2023
- First submitted
- 5 May 2022
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD
- ClinicalTrials.gov ID
- NCT05378828
- Acronym / sponsor ID
- SWADAPT4 / 2021-A03138-33
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties encountered that were not highlighted in previous studies (traffic situations that made daily life difficult for users, need to rework the system)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, Centre Communal d'Action Sociale Saint-Etienne
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 18 May 2022 (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 device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of an electric wheelchair with or without sensors | Other | Device: Using anti-collision Sensors on electric wheelchairs, Other: Use of an electric wheelchair without sensorsDuring 3 weeks, the electric weehlchair will not have sensors, then sensors will be put on the wheelchair for the next 3 weeks then removed for 3 other weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 60 years of age,
- Resident in an institution for the elderly or nursing home,
- with a electric wheelchair but expressing driving difficulties
- Having freely consented to participate in the study,
- In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and having given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient).
Key exclusion criteria (2 listed)
- Impaired comprehension preventing the protocol from being carried out,
- Person in an emergency situation unable to give prior consent
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 |
|---|---|---|
| Using anti-collision Sensors on electric wheelchairsuse of anti-collision sensors on the electric wheelchair during 3 weeks | Device | Use of an electric wheelchair with or without sensors |
| Use of an electric wheelchair without sensorsUse of an electric wheelchair without sensors for 3 weeks before using anti-collision sensors then during 3 weeks after using the anti-collision sensors. | Other | Use of an electric wheelchair with or without sensors |
Primary outcome
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD
Time frame: Day 42
Evaluation by using the under score of confidence of Wheelchair Skill Test questionnaire (WST-Q-T 5.1) during the period of use of the module and at the end. The score goes from 0 to 56 (56 is the higher level of confidence).
5 secondary outcomes
Driving habilities
Time frame: Day 42 and Day 63
Distance traveled measured by sensors on the FRE
Time frame: Day 21, Day 42 and Day 63
Mesure of mental load related to wheelchair mobility
Time frame: Day 21, Day 42 and Day 63
Ease of Use Questionnaire
Time frame: Day 42
Acceptability of anti-collision sensors by users
Time frame: Day 42
Results and safety
The study was stopped early (reason given: difficulties encountered that were not highlighted in previous studies (traffic situations that made daily life difficult for users, need to rework the system)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using anti-collision Sensors on electric wheelchairs and Use of an electric wheelchair without sensors in people with Elderly, run by Pôle Saint Hélier at 3 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 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: stopped early, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: difficulties encountered that were not highlighted in previous studies (traffic situations that made daily life difficult for users, need to rework the system)). Results are not available in the source record.
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?
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD (time frame: Day 42). 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 30 Aug 2023.