Evaluation of a Power Assistance Device for Wheelchair-DUO

NCT03386799 | Completed

• 2 other identifiers: 2016_752017-A02670-53
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Power assistance device; Wheelchair

Outcome Measures

Primary Outcomes (1)

• ESAT questionnaire

  User satisfaction, using 8 items of the ESAT (Echelle de Satisfaction envers une Aide Technique) questionnaire

  at 12 days

Secondary Outcomes (5)

• Success rate during the indoor test (wheelchair skill program)

  at 12 days

• Time to perform the wheelchair skill program

  at 12 days

• Time run

  at 12 days

• Maximal heart rate

  at 12 days

• Effort assessment by the Borg scale

  at 12 days

Study Arms (1)

Patient in wheelchair

Patient in wheelchair with E-motion device

Device: E-motion device

Interventions

E-motion device DEVICE

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

Patient in wheelchair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a motor deficiency (of any origin) needing a manual wheelchair

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Swynghedauw, CHU

Lille, France

Location

MeSH Terms

Conditions

Paraplegia; Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• André Thevenon, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 29, 2017
• Study Start: March 20, 2018
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

FR (1)