Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology. (KER-EXHOME)

Training Phase, Week 1

The training phase for operating the EVE® exoskeleton covers the following functions (designed to ensure that the participant is trained in the use of the EVE® exoskeleton):

• Standing up;
• Testing in free mode;
• Walking;
• Turning round;
• Half-squat;
• Using precision mode;
• Sitting down;
• Carrying out emergency extraction training;
• Archery training, if the participant has no prior experience. Participants will undergo training over 5 sessions, each lasting at least 60 minutes, spread over one week. A minimum of 5 hours' training is required to ensure safety.

Intervention phase, weeks 2 to 4 During this phase, participants will have a 3½-hour session every day (Monday to Friday). During each session, tasks will need to be carried out using the EVE® exoskeleton and the manual wheelchair.

The Canadian Occupational Performance Measure (COPM) will be used to compare perceived satisfaction and performance when carrying out identified activities of daily living using either the EVE® exoskeleton or a manual wheelchair. Using the COPM, satisfaction and performance are assessed on a scale of 1 to 10 (1 = very poor performance and satisfaction, 10 = full performance and satisfaction). MCRO scores show a significant improvement between the start and end of treatment; in the SCI validation study, the average improvement reported is approximately 4.25 points (Performance) and 2.96 points (Satisfaction) between two measurement points.

The MCRO will be carried out at the end of each session using one of the devices (wheelchair or exoskeleton). Two assessments must be carried out per half-day.

Measurement of task performance as reported by the clinician (occupational therapist and physiotherapist). Clinicians assess overall performance on a scale of 1 to 10 (1 being a failure and 10 being optimal performance) after each session.

The PQRS scale will be completed immediately after each task is performed for each of the two devices (wheelchair and PPE). Thus, four scores must be recorded per half-day.

The time will be recorded upon completion of each task, whether carried out in a wheelchair or using the PPE.

Thus, four times will need to be recorded per half-day.

The System Usability Scale (SUS) is a standardised questionnaire for measuring the usability of interactive systems, comprising ten items formulated as affirmative statements. For each statement, the user is asked to indicate their agreement or disagreement using a 5-point Likert scale (1 = Strongly disagree; 5 = Strongly agree). If the user is unsure how to respond to an item, they are asked to answer it anyway by ticking the centre of the scale (score 3).

Its aim is to measure users' perceptions of a product or service based on their experiences.

The SUS will be assessed at the end of each week. Three SUS ratings will be carried out during the intervention phase.

This is a 26-item questionnaire that measures the impact on quality of life (psychosocial effects) of using a functional aid from the perspective of the person with a disability, by assessing three concepts: Competence (12 items), Adaptability (6 items) and Self-esteem (8 items).

When completing the questionnaire, the respondent rates each item on a 7-point Likert scale ranging from -3 ('maximum negative impact') to +3 ('maximum positive impact'). A score of 0 indicates 'no impact'. The final score is the average obtained by adding up the scores for all items and dividing the total by 26.

The F-PIADS will be carried out at the end of the intervention phase. Two assessments will be conducted, one for each device (wheelchair and PPE).

The RPE scale is a valid method for quantifying physical exertion across a wide variety of exercise types.

It comprises the following categories: a scale from 0 to 10: 0 None, 1 Very easy, 2 Quite easy, 3 Moderate, 4 Quite difficult, 5 Difficult, 7 Very difficult, 10 Very, very difficult. This scale will be used to assess the perception of exertion after completing each task, whether performed in a wheelchair or using the EVE® exoskeleton.