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OpenTrials
Completed

NCT Number: NCT03386799

Evaluation of a Power Assistance Device for Wheelchair-DUO

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)

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Key information

Conditions

Paraplegia Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Swynghedauw, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E-motion device

Device

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

Primary outcomes

  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 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

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: EVALDUO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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