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

Neurological Disorder Clinical Trial

— SWADAPT 3  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05459779
• Other study ID #: 2022-A00690-43
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: July 12, 2022

Study information

• Verified date: March 2023
• Source: Pôle Saint Hélier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorder

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
France	Pole Saint-Hélier	Rennes	Bretagne

Sponsors (2)

Lead Sponsor	Collaborator
Pôle Saint Hélier	INSA Rennes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NASA-Task Load Index	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.	Day 1
Secondary	Calculated task load Index	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.	Day 1
Secondary	Spontaneous stress assessment	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.	Day 1
Secondary	Calculated Stress Index	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.	Day 1
Secondary	Ease of Use Questionnaire	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.	Day 1
Secondary	UTAUT (Unified theory of acceptance of technology) questionnaire	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.	Day 1