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.
Key facts
- Who runs it
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 5 people, planned
- Started
- Oct 2026
- Expected to end
- Apr 2027
- Type of study
- Interventional
- Treatments tested
- Carrying out tasks using the EVE exoskeleton and a manual wheelchair.
- Record updated
- 18 September 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
- Anthropometric compatibility with the device (weight, height, lower limb measurements, joint ranges of motion)
- Whether or not they have previous experience of using a PPE
- Participants who have signed the written consent form to take part in the study following full and informed consent
- Participants covered by a social security scheme (beneficiary or eligible dependant) other than the AME
Who cannot take part
- History of osteoporotic fracture(s)
- Progressive intercurrent conditions: pressure ulcers, infection, venous thrombosis
- Cardiovascular or pulmonary conditions contraindicating exercise (e.g. heart failure or coronary artery disease within the last 6 months)
- Untreated or uncontrolled hypertension (SBP > 140 mmHg; DBP > 90 mmHg)
- Decompensated psychiatric or cognitive disorders that may interfere with the proper use of the device
- Inability to operate the device effectively using a manual control interface, due to a functional and/or cognitive impairment, based on the ability to move the joystick in all directions, press and identify the buttons on the manual control interface
- 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)
- Participant of legal age subject to a legal protection order or unable to give informed consent
- Pregnant or breastfeeding women, or women of childbearing age not using contraception
- 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
- Unresolved orthostatic hypotension (SBP < 90 mmHg; DBP < 60 mmHg) or deemed contraindicated by the investigator
- Unconsolidated or unstable bone lesions of the spine, limbs or pelvis
- Known syringomyelia, as determined by medical assessment
- Progressive osteoma, as determined by medical assessment
- Severe spasticity of the adductor muscles, hamstrings, quadriceps and triceps surae (greater than 3 on the modified Ashworth scale)
- Stoma
- Wearing of an active implantable device An uncorrectable leg-length discrepancy of more than 2 cm when using additional corrective aids
- Uncontrolled autonomic dysreflexia
- Skin lesions at points of contact with the PPE (e.g. bruising, skin abrasions, etc.)
- Need to use a respiratory support device whilst using Eve
- Incorrect positioning of the participant in the device (excessive pressure on the support point)
- Participant deprived of liberty (by court order or administrative decision)
- Participation in another ongoing clinical trial
- Lack of proficiency in spoken and written French
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Carrying out tasks using the EVE exoskeleton and a manual wheelchair.Treatment being tested
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07828912, who can take part
- Record updated
- 18 September 2026