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

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ClinicalTrials.gov Identifier: NCT03386799
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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)


Condition or disease Intervention/treatment
Paraplegia Hemiplegia Device: E-motion device

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Power Assistance Device for Wheelchair-DUO
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. ESAT questionnaire [ Time Frame: at 12 days ]
    User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire


Secondary Outcome Measures :
  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 [ Time Frame: at 12 days ]
    During a 500 m outdoor run

  4. Maximal heart rate [ Time Frame: at 12 days ]
    During a 500 m outdoor run

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a motor deficiency (of any origin) needing a manual wheelchair
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386799


Contacts
Contact: Maguerite Preud'Homme, MD,PhD 320 445 832 ext +33 marguerite.preudhomme@chru-lille.fr

Locations
France
Hôpital Swynghedauw, CHU Recruiting
Lille, France
Principal Investigator: Marguerite Preud'homme, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Marguerite Preud'Homme, MD,PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03386799     History of Changes
Other Study ID Numbers: 2016_75
2017-A02670-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Power assistance device
Wheelchair

Additional relevant MeSH terms:
Hemiplegia
Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms