Evaluation of a Power Assistance Device for Wheelchair-DUO

Hemiplegia Clinical Trial

— EVALDUO  

Official title:

Evaluation of a Power Assistance Device for Wheelchair-DUO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386799
• Other study ID #: 2016_75
• Secondary ID: 2017-A02670-53
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: April 21, 2021

Study information

• Verified date: July 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Paraplegia

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Swynghedauw, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESAT questionnaire	User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire	at 12 days
Secondary	Success rate during the indoor test (wheelchair skill program)		at 12 days
Secondary	Time to perform the wheelchair skill program		at 12 days
Secondary	Time run	During a 500 m outdoor run	at 12 days
Secondary	Maximal heart rate	During a 500 m outdoor run	at 12 days
Secondary	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