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

Neurological Disorder Clinical Trial

— SWADAPT2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259151
• Other study ID #: 2019-A01306-51
• Status: Completed
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• 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, 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• 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 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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorder

Intervention

Device:
• Electric wheelchair with activated assistance module
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
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

Locations

Country	Name	City	State
France	Pôle Saint-Hélier	Rennes	Bretagne

Sponsors (2)

Lead Sponsor	Collaborator
Pôle Saint Hélier	Institut National des Sciences Appliquées de Rennes (INSA)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Driving Speed	Speed measured by the completion time of the course with and without activation of the assistance system on the different circuits	Day 1, Day 8 and Day 15
Secondary	Wheelchair Skill Test	Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses, with and without activation of the assistance system	Day 1, Day 8 and Day 15
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)	Day 1, Day 8 and Day 15
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 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).	Day 1, Day 8 and Day 15
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).	Day 1, Day 8 and Day 15