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

NCT04259151 | Completed

• 1 other identifier: 2019-A01306-51
• 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, 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.

Conditions

Neurological Disorder

Outcome Measures

Primary Outcomes (3)

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.

  Day 1

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.

  Day 8

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.

  Day 15

Secondary Outcomes (5)

• Driving Speed

  Day 1, Day 8 and Day 15

• Wheelchair Skill Test

  Day 1, Day 8 and Day 15

• NASA-Task Load Index

  Day 1, Day 8 and Day 15

• Ease of Use Questionnaire

  Day 1, Day 8 and Day 15

• UTAUT (Unified theory of acceptance of technology) questionnaire

  Day 1, Day 8 and Day 15

Study Arms (2)

Electric wheelchair with activated assistance module

EXPERIMENTAL

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.

Device: Electric wheelchair with activated assistance module

Electric wheelchair with assistance module not activated

OTHER

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.

Device: Electric wheelchair with assistance module not activated

Interventions

Electric wheelchair with activated assistance module DEVICE

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

Electric wheelchair with activated assistance module

Electric wheelchair with assistance module not activated DEVICE

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 no activated 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• INSA Rennes: collaborator

Study Sites (1)

Pôle 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• 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: OTHER
• 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. 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.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: June 25, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-07

Locations

FR (1)