Evaluation of a Power Assistance Device for Wheelchair-DUO

Completed

• Conditions: Hemiplegia; Paraplegia
• Interventions: Device: E-motion device

• Registration Number: NCT03386799
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2018-03-20
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient in wheelchair	E-motion device	Patient in wheelchair with E-motion device

Primary Outcome Measures

Name	Time	Method
ESAT questionnaire	at 12 days	User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire

Secondary Outcome Measures

Name	Time	Method
Success rate during the indoor test (wheelchair skill program)	at 12 days
Time run	at 12 days	During a 500 m outdoor run
Time to perform the wheelchair skill program	at 12 days
Maximal heart rate	at 12 days	During a 500 m outdoor run
Effort assessment by the Borg scale	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

Trial Locations

Locations (1)

Hôpital Swynghedauw, CHU; 🇫🇷 Lille, France