ClinicalTrials.gg
CompletedNCT03386799EVALDUOUpdated Jul 12, 2022

Evaluation of a Power Assistance Device for Wheelchair-DUO

An observational study in Paraplegia and Hemiplegia, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Paraplegia with a site in France — 3 open to participants now, 4 under way, none of them phase 3. Paraplegia · France.

Enrollment
8th of 10
27 · median 48
Started
2018
with 2 others
Observational
10 of 24
1 open now
Registered
10th of 24
by date

Among the 24 studies in Paraplegia with a site in France, this one is the 8th largest by enrollment of the 10 observational ones that give a count, is one of 3 that started in 2018, is one of 10 observational ones, and was the 10th registered.

Paraplegia

151 studies on the registry are indexed under Paraplegia; 36 are open to participants now.

Browse Paraplegia studies →

Open to participants now

3 of the 24 studies in Paraplegia with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 32 Paraplegia studies recruiting now, 15 (47%) set no upper age limit and 14 (44%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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)

03

Conditions studied

  • Paraplegia
  • Hemiplegia

Keywords

  • Power assistance device
  • Wheelchair
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a motor deficiency (of any origin) needing a manual wheelchair

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • in keeping a seating position especially the occurrence of ulcers.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient in wheelchair

    Patient in wheelchair with E-motion device

    Device: E-motion device

Interventions

  • DeviceE-motion device

    Powered assisted Wheelchair with the E-motion device. Outdoor and indoor runs

06

What researchers measure

Primary outcomes

  1. ESAT questionnaire

    User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire

    Time frame: at 12 days

Secondary outcomes

  1. Success rate during the indoor test (wheelchair skill program)

    Time frame: at 12 days

  2. Time to perform the wheelchair skill program

    Time frame: at 12 days

  3. Time run

    During a 500 m outdoor run

    Time frame: at 12 days

  4. Maximal heart rate

    During a 500 m outdoor run

    Time frame: at 12 days

  5. 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

    Time frame: at 12 days

07

Study locations

1 site
  • Hôpital Swynghedauw, CHU
    Lille, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Apr 2021, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2017
First posted
Dec 29, 2017
StartActual
Mar 20, 2018
Primary completionActual
Apr 21, 2021
CompletionActual
Apr 21, 2021
Last update
Jul 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03386799
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Mar 20, 2018
Primary completion
Apr 21, 2021
Completion
Apr 21, 2021
Last update
Jul 12, 2022

Study contacts

André Thevenon, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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