Neurological DisorderSWADAPT 3NCT05459779
Evaluation of a Robotic Assistance Module Against Positive and Negative Obstacles for Driving Electric Wheelchair
A study testing Electric wheelchair with activated assistance module and Electric wheelchair with assistance module not activated in people with Neurological Disorder, run by Pôle Saint Hélier at 1 site in France.
Trial summary
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorder
- What is being tested?
- Electric wheelchair with activated assistance module and Electric wheelchair with assistance module not activated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2022to 12 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18,
- Having read the information note and freely consented to participate in the study,
- Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
- Having benefited from an electric wheelchair prescription and/or learning to drive,
- The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.
Who cannot join
- Understanding difficulties preventing the realization of the protocol,
- Motor disorders of the upper limb requiring additional driving technical assistance,
- Patient who has expressed difficulties impacting their internal and/or external driving safety,
- Pregnant, parturient or breastfeeding women,
- A person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
- Minors,
- a person in an emergency situation, unable to express his prior consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.
Read the detailed description
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. The robotic assistance module is program to detect positive and negative obstacles.
This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions:
Each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.
- Conditions
- Neurological Disorder
- Being tested
- Electric wheelchair with activated assistance module, Electric wheelchair with assistance module not activated
- 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.
Electric wheelchair with activated assistance moduleDevice
This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance.
Electric wheelchair with assistance module not activatedDevice
This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activating assistance.
| Study group | Role | What they receive |
|---|---|---|
| Electric wheelchair with activated assistance module | Experimental | This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance, in a random order established upstream. Receives: Device: Electric wheelchair with activated assistance module |
| Electric wheelchair with assistance module not activated | Other | This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activated assistance, in a random order established upstream. Receives: Device: Electric wheelchair with assistance module not activated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Pass rate across standard platforms. The platform has been divided into sectors. The crossing of the platform stops as soon as a failure occurs (swing or collision). The circuit is composed of 9 platforms divided into 91 sectors. At the end, the success rate corresponds to the numbers of sector past with success with and without activation of the assistance system.
Score rate : 0-91
Measured: Day 1
Secondary outcomes (6)
NASA-Task Load Index
The cognitive load of tests under both conditions 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), with and without activation of the assistance system.
Measured: Day 1
Calculated task load Index
During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a task load Index. The score ranges between 0 and 5 with 5 being the most demanding. The score will be measured before and after each condition.
Measured: Day 1
Spontaneous stress assessment
The spontaneous stress measured by Visual Analogic Scale, from 0 to 100. The 0 represents not stressed at all and 100 extremely stressed. The score will be measured before and after each condition.
Measured: Day 1
Calculated Stress Index
During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a Stress Index. The score ranges between 0 and 100 with 100 being the most stressful. The score will be measured before and after each condition.
Measured: Day 1
Ease of Use Questionnaire
The satisfaction of the use of the electric wheelchair under the conditions will be evaluated by the self-questionnaire Ease of Use Questionnaire. It measures the subjective usability of a product or service. It is a 28-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The questionnaires were constructed as seven-point Likert rating scales. Users were asked to rate agreement with the statements, ranging from strongly disagree (1) to strongly agree (7). The score will be measured after each condition.
Measured: Day 1
UTAUT (Unified theory of acceptance of technology) questionnaire
Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT). The score will be measured at the end of the evaluation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start8 Jul 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- INSA Rennes
- Responsible party
- Sponsor
- Investigators
- Philippe Gallien, Doctor, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459779
- Sponsor's protocol ID
- 2022-A00690-43
- Acronym
- SWADAPT 3
- Status last verified
- Mar 2023
- First submitted
- 1 Jul 2022
- Last updated
- 29 Mar 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.
- ClinicalTrials.gov ID
- NCT05459779
- Acronym / sponsor ID
- SWADAPT 3 / 2022-A00690-43
- Conditions
- Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- INSA Rennes
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 15 Jul 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 that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.
Detailed description
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. The robotic assistance module is program to detect positive and negative obstacles.
This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions:
Each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not.
| Arm | Type | Receives |
|---|---|---|
| Electric wheelchair with activated assistance module | Experimental | Device: Electric wheelchair with activated assistance moduleThis condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance, in a random order established upstream. |
| Electric wheelchair with assistance module not activated | Other | Device: Electric wheelchair with assistance module not activatedThis condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activated assistance, in a random order established upstream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18,
- Having read the information note and freely consented to participate in the study,
- Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
- Having benefited from an electric wheelchair prescription and/or learning to drive,
- The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.
Key exclusion criteria (7 listed)
- Understanding difficulties preventing the realization of the protocol,
- Motor disorders of the upper limb requiring additional driving technical assistance,
- Patient who has expressed difficulties impacting their internal and/or external driving safety,
- Pregnant, parturient or breastfeeding women,
- A person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
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 |
|---|---|---|
| Electric wheelchair with activated assistance moduleThis evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance. | Device | Electric wheelchair with activated assistance module |
| Electric wheelchair with assistance module not activatedThis evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activating assistance. | Device | Electric wheelchair with assistance module not activated |
Primary outcome
Success rate
Time frame: Day 1
Pass rate across standard platforms. The platform has been divided into sectors. The crossing of the platform stops as soon as a failure occurs (swing or collision). The circuit is composed of 9 platforms divided into 91 sectors. At the end, the success rate corresponds to the numbers of sector past with success with and without activation of the assistance system. Score rate : 0-91
6 secondary outcomes
NASA-Task Load Index
Time frame: Day 1
Calculated task load Index
Time frame: Day 1
Spontaneous stress assessment
Time frame: Day 1
Calculated Stress Index
Time frame: Day 1
Ease of Use Questionnaire
Time frame: Day 1
UTAUT (Unified theory of acceptance of technology) questionnaire
Time frame: Day 1
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 29 Mar 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.
Philippe Gallien, Doctor principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric wheelchair with activated assistance module and Electric wheelchair with assistance module not activated in people with Neurological Disorder, run by Pôle Saint Hélier 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 5 inclusion and 7 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 29 Mar 2023. 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?
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?
Success rate (time frame: Day 1). 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 29 Mar 2023.