Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving (SWADAPT1)

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

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.

Study Overview

• Status: Completed
• Conditions: Neurological Disorders
• Intervention / Treatment: Device: Electric wheelchair with activated assistance module; Device: Electric wheelchair with assistance module not activated

Detailed 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Pôle Saint-Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged over 18,
• Having freely consented to participate in the study,
• suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
• Having benefited from a prescription of electric wheelchair and circulating in an electric wheelchair for more than 3 months,
• of which the electric wheelchair is the main mode of transport,
• 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 having expressed difficulties impacting his safety of sedan and / or exterior.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2019-A00476-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No