ParaplegiaEVALDUONCT03386799
Evaluation of a Power Assistance Device for Wheelchair-DUO
An observational study of Paraplegia and Hemiplegia, run by University Hospital, Lille at 1 site in France.
Trial summary
Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraplegia, Hemiplegia
- What is being tested?
- E-motion device
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2018to 21 Apr 2021
- Phase
- Observational
- 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
Study population: Patient with a motor deficiency (of any origin) needing a manual wheelchair
Who may be able to join
- with a motor deficiency (of any origin) needing a manual wheelchair
- propelling his wheelchair with both arms or with one foot and one arm.
- covered by the French national health insurance.
- living at less than 30km form the investigation center
Who cannot join
- subject of a guardianship or tutelage measure
- owning already a power wheelchair or a powered assisted wheelchair
- with cognitive impairments that affect the steering capacity or the understanding of the instructions.
- Patient unable to use a manual wheelchair indoor without help,
- Contraindication in keeping a seating position especially the occurrence of ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.
Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.
Read more
To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.
The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.
The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)
- Conditions
- Paraplegia, Hemiplegia
- Being tested
- E-motion device
- Keywords
- Power assistance device, Wheelchair
- Medical subject headings
- Paraplegia, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-motion deviceDevice
Powered assisted Wheelchair with the E-motion device. Outdoor and indoor runs
| Study group | Role | What they receive |
|---|---|---|
| Patient in wheelchair | Patient in wheelchair with E-motion device Receives: Device: E-motion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESAT questionnaire
User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire
Measured: at 12 days
Secondary outcomes (5)
Success rate during the indoor test (wheelchair skill program)
Measured: at 12 days
Time to perform the wheelchair skill program
Measured: at 12 days
Time run
During a 500 m outdoor run
Measured: at 12 days
Maximal heart rate
During a 500 m outdoor run
Measured: at 12 days
Effort assessment by the Borg scale
During a 500 m outdoor run The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and will be used to rate the intensity of dyspnea
Measured: at 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start20 Mar 2018
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Thevenon, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386799
- Sponsor's protocol ID
- 2016_75
- Other IDs
- 2017-A02670-53
- Acronym
- EVALDUO
- Status last verified
- Jul 2022
- First submitted
- 18 Dec 2017
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Power Assistance Device for Wheelchair-DUO
- ClinicalTrials.gov ID
- NCT03386799
- Acronym / sponsor ID
- EVALDUO / 2016_75
- Conditions
- Paraplegia, Hemiplegia
- Keywords
- Power assistance device, Wheelchair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 29 Dec 2017 (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.
Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.
Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.
To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.
The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.
The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in wheelchair | – | Device: E-motion devicePatient in wheelchair with E-motion device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a motor deficiency (of any origin) needing a manual wheelchair
Key inclusion criteria (4 listed)
- with a motor deficiency (of any origin) needing a manual wheelchair
- propelling his wheelchair with both arms or with one foot and one arm.
- covered by the French national health insurance.
- living at less than 30km form the investigation center
Key exclusion criteria (5 listed)
- subject of a guardianship or tutelage measure
- owning already a power wheelchair or a powered assisted wheelchair
- with cognitive impairments that affect the steering capacity or the understanding of the instructions.
- Patient unable to use a manual wheelchair indoor without help,
- Contraindication in keeping a seating position especially the occurrence of ulcers.
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 |
|---|---|---|
| E-motion devicePowered assisted Wheelchair with the E-motion device. Outdoor and indoor runs | Device | Patient in wheelchair |
Primary outcome
ESAT questionnaire
Time frame: at 12 days
User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire
5 secondary outcomes
Success rate during the indoor test (wheelchair skill program)
Time frame: at 12 days
Time to perform the wheelchair skill program
Time frame: at 12 days
Time run
Time frame: at 12 days
Maximal heart rate
Time frame: at 12 days
Effort assessment by the Borg scale
Time frame: at 12 days
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 12 Jul 2022.
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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.
André Thevenon, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraplegia and Hemiplegia, run by University Hospital, Lille 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 4 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 12 Jul 2022. 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?
ESAT questionnaire (time frame: at 12 days). 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 12 Jul 2022.