Evaluation of a Power Assistance Device for Wheelchair-DUO

Study Overview
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Brief Summary
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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)

Official Title
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Evaluation of a Power Assistance Device for Wheelchair-DUO

Conditions
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Hemiplegia, Paraplegia

Intervention / Treatment
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* Device: E-motion device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient in wheelchair<br>Patient in wheelchair with E-motion device | Device: E-motion device<br>* Powered assisted Wheelchair with the E-motion device. Outdoor and indoor runs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESAT questionnaire | 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) |  | at 12 days | 
| Time to perform the wheelchair skill program |  | at 12 days | 
| Time run | During a 500 m outdoor run | at 12 days | 
| Maximal heart rate | During a 500 m outdoor run | at 12 days | 
| Effort assessment by the Borg scale | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Power assistance device, Wheelchair