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Completed

NCT Number: NCT05459779

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

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.

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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

Pole 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. 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.

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 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Success rate

    Time frame: Day 1

    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

Secondary outcomes

  1. NASA-Task Load Index

    Time frame: Day 1

    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), with and without activation of the assistance system.

  2. Calculated task load Index

    Time frame: Day 1

    During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a task load Index. The score ranges between 0 and 5 with 5 being the most demanding. The score will be measured before and after each condition.

  3. Spontaneous stress assessment

    Time frame: Day 1

    The spontaneous stress measured by Visual Analogic Scale, from 0 to 100. The 0 represents not stressed at all and 100 extremely stressed. The score will be measured before and after each condition.

  4. Calculated Stress Index

    Time frame: Day 1

    During the evaluation, physiological signals (cardiac frequency /electroencephalography/Electro dermal activity) will be measured by skin sensors. The signals will be used to calculate a Stress Index. The score ranges between 0 and 100 with 100 being the most stressful. The score will be measured before and after each condition.

  5. Ease of Use Questionnaire

    Time frame: Day 1

    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 28-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). The score will be measured after each condition.

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

    Time frame: Day 1

    Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT). The score will be measured at the end of the evaluation.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Collaborators

  • INSA Rennes

Registry information

Official study title

Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.

Acronym: SWADAPT 3

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2022
Registry last updated
Mar 29, 2023

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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