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.

The KER-EXHOME study is a single-case experimental design (SCED) with multiple baseline conditions. This methodology enables the analysis of data from a limited number of subjects and is based on three principles: each subject serves as their own control; frequent, repeated measurement of each subject's performance throughout the study phase; and the sequential, randomised introduction of the intervention during the study, which ensures the necessary statistical power.

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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);
• 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)
• Decompensated psychiatric or cognitive disorders that may interfere with the proper use of the device
• 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
• 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.
• Incorrect positioning of the participant in the device (excessive pressure on the support point).
• Participant deprived of liberty (by court order or administrative decision)
• Participant of legal age subject to a legal protection order or unable to give informed consent
• Participation in another ongoing clinical trial
• Pregnant or breastfeeding women, or women of childbearing age not using contraception
• Lack of proficiency in spoken and written French