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

NCT05459779 | Completed

• 1 other identifier: 2022-A00690-43
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Disorder

Outcome Measures

Primary Outcomes (1)

• Success rate

  Pass rate across standard platforms. The platform has been divided into sectors. The crossing of the platform stops as soon as a failure occurs (swing or collision). The circuit is composed of 9 platforms divided into 91 sectors. At the end, the success rate corresponds to the numbers of sector past with success with and without activation of the assistance system. Score rate : 0-91

  Day 1

Secondary Outcomes (6)

• NASA-Task Load Index

  Day 1

• Calculated task load Index

  Day 1

• Spontaneous stress assessment

  Day 1

• Calculated Stress Index

  Day 1

• Ease of Use Questionnaire

  Day 1

Study Arms (2)

Electric wheelchair with activated assistance module

EXPERIMENTAL

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.

Device: Electric wheelchair with activated assistance module

Electric wheelchair with assistance module not activated

OTHER

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.

Device: Electric wheelchair with assistance module not activated

Interventions

Electric wheelchair with activated assistance module 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 activated assistance module

Electric wheelchair with assistance module not activated 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.

Electric wheelchair with assistance module not activated

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• INSA Rennes: collaborator

Study Sites (1)

Pole Saint-Hélier

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Philippe Gallien, Doctor

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To minimize bias, this study will be randomized and conducted in single blind. The patient will not be aware of the activation or not of the assistance module placed on the electric wheelchair. Indeed, the investigative team will be in charge of the activation of the robotic module.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 15, 2022
• Study Start: July 8, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

FR (1)