Evaluation of a Robotic Assistance Module Against Positive and Negative Obstacles for Driving Electric Wheelchair

NCT ID: NCT05459779

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2022-07-12

Brief Summary

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, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.

Detailed 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. The robotic assistance module is program to detect positive and negative obstacles.

This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions:

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

Conditions

Neurological Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Electric wheelchair with activated assistance module

This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance, in a random order established upstream.

Group Type: EXPERIMENTAL

Electric wheelchair with activated assistance module

Intervention Type: DEVICE

This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance.

Electric wheelchair with assistance module not activated

This condition will be achieved in a standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activated assistance, in a random order established upstream.

Group Type: OTHER

Electric wheelchair with assistance module not activated

Intervention Type: DEVICE

This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activating assistance.

Interventions

Electric wheelchair with activated assistance module

This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 with activated assistance.

Intervention Type: DEVICE

Electric wheelchair with assistance module not activated

This evaluation will be carried out in 1 standardized test circuit composed by 9 platforms of increasing difficulty. The same day, the patient will perform the circuit 4 times, including 2 without activating assistance.

Intervention Type: DEVICE

Eligibility Criteria

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 and/or learning to drive,
• 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,
• Patient who has expressed difficulties impacting their internal and/or external driving safety,
• Pregnant, parturient or breastfeeding women,
• A person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
• Minors,
• a person in an emergency situation, unable to express his prior consent.

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

Sponsors

INSA Rennes

OTHER

Sponsor Role: collaborator

Pôle Saint Hélier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Gallien, Doctor

Role: PRINCIPAL_INVESTIGATOR

Pôle Saint Hélier

Locations

Pole Saint-Hélier

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2022-A00690-43

Identifier Type: -

Identifier Source: org_study_id