Evaluation of a Power Assistance Device for Wheelchair-DUO

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Brief Title

Evaluation of a Power Assistance Device for Wheelchair-DUO

Official Title

Evaluation of a Power Assistance Device for Wheelchair-DUO

Brief 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)
    



Study Type

Observational


Primary Outcome

ESAT questionnaire

Secondary Outcome

 Success rate during the indoor test (wheelchair skill program)

Condition

Paraplegia

Intervention

E-motion device

Study Arms / Comparison Groups

 Patient in wheelchair
Description:  Patient in wheelchair with E-motion device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

30

Start Date

March 20, 2018

Completion Date

June 2020

Primary Completion Date

June 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

André Thevenon, MD,PhD, 320 445 832, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03386799

Organization ID

2016_75

Secondary IDs

2017-A02670-53

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille


Study Sponsor

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


Verification Date

August 2019