Evaluation of a Power Assistance Device for Wheelchair-DUO (EVALDUO)

July 11, 2022 updated by: University Hospital, Lille

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Swynghedauw, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient in wheelchair
Patient in wheelchair with E-motion device
Device: E-motion device
Powered assisted Wheelchair with the E-motion device. Outdoor and indoor runs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ESAT questionnaire
Time Frame: at 12 days
User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire
at 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate during the indoor test (wheelchair skill program)
Time Frame: at 12 days
at 12 days
Time to perform the wheelchair skill program
Time Frame: at 12 days
at 12 days
Time run
Time Frame: at 12 days
During a 500 m outdoor run
at 12 days
Maximal heart rate
Time Frame: at 12 days
During a 500 m outdoor run
at 12 days
Effort assessment by the Borg scale
Time Frame: at 12 days
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
at 12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: André Thevenon, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

April 21, 2021

Study Completion (Actual)

April 21, 2021

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_75
  • 2017-A02670-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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