Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving (SWADAPT2)

Pôle Saint Hélier

Status: Completed

Conditions: Neurological Disorder

Treatments: Device: Electric wheelchair with activated assistance module; Device: Electric wheelchair with assistance module not activated

Study type: Interventional

Funder types: Other

Identifiers

NCT04259151

2019-A01306-51

Details and patient eligibility

About

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

Full description

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

This study "SWADAPT2" follows "SWADAPT1" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions :

Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged over 18,
• Having read the information note and freely consented to participate in the study,
• Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
• Having benefited from an electric wheelchair prescription or learning to drive.
• Having difficulties driving an electric wheelchair impacting their indoor and/or outdoor driving safety, as shown by the WST score.
• The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.

Exclusion criteria

• Understanding difficulties preventing the realization of the protocol,
• Motor disorders of the upper limb requiring additional driving technical assistance.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Electric wheelchair with activated assistance module

Experimental group

Description:

This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Treatment:

Device: Electric wheelchair with activated assistance module

Electric wheelchair with assistance module not activated

Other group

Description:

This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 without activated assistance, in a random order established upstream.

Treatment:

Device: Electric wheelchair with assistance module not activated