Evaluation of a Power Assistance Device for Wheelchair-DUO

NCT ID: NCT03386799

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2021-04-21

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)

Conditions

Paraplegia; Hemiplegia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient in wheelchair

Patient in wheelchair with E-motion device

E-motion device

Intervention Type: DEVICE

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

Interventions

E-motion device

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

André Thevenon, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Swynghedauw, CHU

Lille, , France

Countries

France

Other Identifiers

2017-A02670-53

Identifier Type: OTHER

Identifier Source: secondary_id

2016_75

Identifier Type: -

Identifier Source: org_study_id