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
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|
|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|
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
- ESAT questionnaire [ Time Frame: at 12 days ]User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire
- Success rate during the indoor test (wheelchair skill program) [ Time Frame: at 12 days ]
- Time to perform the wheelchair skill program [ Time Frame: at 12 days ]
- Time run [ Time Frame: at 12 days ]During a 500 m outdoor run
- Maximal heart rate [ Time Frame: at 12 days ]During a 500 m outdoor run
- 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
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
|Contact: Maguerite Preud'Homme, MD,PhD||320 445 832 ext +email@example.com|
|Hôpital Swynghedauw, CHU||Recruiting|
|Principal Investigator: Marguerite Preud'homme, MD,PhD|
|Principal Investigator:||Marguerite Preud'Homme, MD,PhD||University Hospital, Lille|