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Completed

NCT Number: NCT04259151

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

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.

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Key information

Conditions

Neurological Disorder Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle Saint-Hélier

Rennes, Brittany Region, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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

Primary outcomes

  1. Number of collision

    Time frame: Day 1

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

  2. Number of collision

    Time frame: Day 8

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

  3. Number of collision

    Time frame: Day 15

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

Secondary outcomes

  1. Driving Speed

    Time frame: Day 1, Day 8 and Day 15

    Speed measured by the completion time of the course with and without activation of the assistance system on the different circuits

  2. Wheelchair Skill Test

    Time frame: Day 1, Day 8 and Day 15

    Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses, with and without activation of the assistance system

  3. NASA-Task Load Index

    Time frame: Day 1, Day 8 and Day 15

    The cognitive load of tests under both conditions will be measured by the NASA-Task Load Index. It is in the form of six scales where the participant must assign a score between zero and one hundred to each of them, score indicating a growing level of intensity. Three dimensions relate to the demands imposed on the subject (mental, physical and temporal demands) and three to the interaction of a subject with the task (effort, frustration and performance)

  4. Ease of Use Questionnaire

    Time frame: Day 1, Day 8 and Day 15

    The satisfaction of the use of the electric wheelchair under the conditions will be evaluated by the self-questionnaire Ease of Use Questionnaire. It measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The questionnaires were constructed as seven-point Likert rating scales. Users were asked to rate agreement with the statements, ranging from strongly disagree (1) to strongly agree (7).

  5. UTAUT (Unified theory of acceptance of technology) questionnaire

    Time frame: Day 1, Day 8 and Day 15

    Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT).

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Collaborators

  • INSA Rennes

Registry information

Official study title

Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, in Difficulty Driving of Electric Wheelchairs

Acronym: SWADAPT2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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