Spinal cord injuries resulting in paraplegia affect patients' mobility and, consequently, their ability to participate in activities of daily living. In France, according to available sources, the number of people with a symptomatic spinal cord injury is estimated to be between 97,000 and 132,000, with an average age of 55. The incidence is estimated at 1,300 new cases per year.
Following initial treatment, patients' aim is to resume their daily activities. Engaging in these activities is associated with a better quality of life and is recognised as having a positive effect on health. Limitations in their ability to move around directly affect their participation in activities of daily living and, consequently, their quality of life.
To this end, mobility can be supported by a manual wheelchair (MW) or an electric wheelchair (EW); however, these aids do not enable patients to regain the ability to stand, which remains one of the main goals for people with spinal cord injuries.
Robotic exoskeletons can assist with standing and locomotion. To date, robotic exoskeletons have been used in rehabilitation centres. During the rehabilitation phase, these devices have proven to be usable and safe for a wide range of patients with spinal cord injuries. Motorised exoskeletons thus enable patients to perform tasks such as walking, standing upright, rotating, and carrying out dynamic balance exercises.
In the longer term, personal exoskeletons, used at home, could facilitate the performance of productive, domestic, social or recreational activities, such as those carried out on a daily basis by every individual.
Personal powered exoskeletons (PPEs) also appear to generate physiological and psychosocial benefits. Studies describe potential improvements in cardiovascular health, bladder and sphincter function, and a reduced risk of osteoporosis. After a few weeks of training with a motorised exoskeleton, patients report improvements in social functioning, mental health and sub-domains of general health perception on the SF36 Walk Wheel.
It should be noted that the ability to interact socially whilst standing is an important aspect of quality of life for patients with spinal cord injuries. Patients describe the pleasure of eye contact, of being able to walk with assistance, and an improvement in mood. The PPE would complement the wheelchair by enabling ambulation and participation in activities whilst standing.
Preserving upper limb function is a prerequisite for the widespread use of walking exoskeletons in everyday life. A self-supporting PPE, such as the EVE® device, which does not require the use of crutches, aims to enable users to stand up and walk whilst retaining the use of their upper limbs. This active balance control is a crucial function for achieving many functional skills in a domestic environment. One of the technological advantages of the self-balancing exoskeleton lies in the use of dynamics to eliminate the need for crutches, whilst ensuring walking safety.
The next step towards the development of personal exoskeletons for people with spinal cord injuries is to investigate the performance of activities of daily living whilst wearing an exoskeleton. To our knowledge, no such study has been carried out, and our work addresses a gap in the scientific literature by analysing the impact of using a self-propelled PPE on satisfaction and performance when carrying out activities of daily living.
The investigators hypothesise that the personal exoskeleton leads to greater satisfaction when carrying out the four tasks of daily living, compared with that achieved using a manual wheelchair.
In this context, the KER-EXHOME clinical trial, proposed by Dr Stéphanie LEPLAIDEUR (coordinator of this study), and led by the Kerpape Centre (sponsor), aims to compare, in participants with paraplegia, satisfaction and performance when carrying out activities of daily living and physical activities, using the EVE® device compared with a manual wheelchair.
Clinical presentation of paraplegia at a level between T5 and L5 inclusive, AIS A to C inclusive
Secondary to a spinal cord injury (traumatic or non-traumatic) occurring more than 6 months ago, clinically and functionally stable
Using a manual wheelchair for indoor and outdoor mobility
Able to tolerate 45 minutes of standing per day
Osteoporosis with a T-score < -2.5 at the femoral neck, as shown by a bone densitometry scan carried out within the last 12 months.
History of osteoporotic fracture(s)
Condition or treatment causing secondary osteoporosis (known thyroid disorder, known hypogonadism, known chronic gastrointestinal disease (ulcerative colitis and Crohn's disease), corticosteroid therapy, use of bisphosphonates for more than three months, early menopause (before the age of 45), abnormal calcium metabolism test results)
Progressive intercurrent conditions: pressure ulcers, infection, venous thrombosis
Single group
Carrying out tasks using the EVE exoskeleton and a manual wheelchair.
DeviceEach day (Monday to Friday), participants will have a 3½-hour session. During each session, tasks will need to be carried out using the EVE® exoskeleton and the manual wheelchair. The tasks have been grouped in pairs so that two tasks are carried out in succession. These task groups have been assigned a number, as follows: 1- Archery and retrieving a parcel 2- Making coffee and brushing teeth During a session, the participant will carry out one task group using both devices: the EVE® exoskeleton and the manual wheelchair. These devices have been assigned a letter, as follows: A- EVE® exoskeleton B- Manual wheelchair A random allocation will be used to determine the order of the parameters (B-wheelchair or A-EVE® exoskeleton), the time of day (morning or afternoon), and the task group to be performed in each session for each participant (1 or 2).
Compare satisfaction and performance when carrying out four activities of daily living using the EVE® exoskeleton, versus those carried out using a manual wheelchair, using the Canadian Occupational Performance Measure (COPM)
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.
Compare user-assessed performance with clinician-assessed performance, using the Performance Quality Rating Scale (PQRS)
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.
Time taken to complete each task (in seconds).
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.
To evaluate the user's perception of the ease of use of the EVE® exoskeleton, using the System Usability Scale (SUS)
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.
To assess the psychosocial impact of the EVE® exoskeleton using the French-Canadian version of the F-PIADS scale, which measures the psychosocial impact of an assistive device.
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).
Click on the lead sponsor to view all of their trials.
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Lead sponsor
Groupement des Hôpitaux de l'Institut Catholique de Lille
Collaborator
Wandercraft
Collaborator
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