SWADAPT2: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving

Sponsor

Pôle Saint Hélier (Other)

Overall Status

Completed

CT.gov ID

NCT04259151

Collaborator

Institut National des Sciences Appliquées de Rennes (INSA) (Other)

Enrollment

Location

Arms

15.2

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurological Disorder	Device: Electric wheelchair with activated assistance module Device: Electric wheelchair with assistance module not activated	N/A

Detailed Description

This study "SWADAPT2" follows "SWADAPT1" with patients with Neurological Disorders, Regular

Drivers of Electric Wheelchairs, in the same conditions :

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Other

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

Actual Study Start Date :

Jun 25, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electric wheelchair with activated assistance module 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 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
Other: Electric wheelchair with assistance module not activated 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 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

Arm

Intervention/Treatment

Experimental: Electric wheelchair with activated assistance module

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

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

Other: Electric wheelchair with assistance module not activated

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

Outcome Measures

Primary Outcome Measures

Number of collision [Day 1]
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
Number of collision [Day 8]
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
Number of collision [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 Outcome Measures

Driving Speed [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
Wheelchair Skill Test [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
NASA-Task Load Index [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)
Ease of Use Questionnaire [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).
UTAUT (Unified theory of acceptance of technology) questionnaire [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pôle Saint-Hélier	Rennes	Bretagne	France	35000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Philippe Gallien, Doctor, Pôle Saint Hélier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pôle Saint Hélier

ClinicalTrials.gov Identifier:

NCT04259151

Other Study ID Numbers:

2019-A01306-51

First Posted:

Feb 6, 2020

Last Update Posted:

Nov 1, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nervous System Diseases

Study Results

No Results Posted as of Nov 1, 2021