Self-balancing Personal Exoskeleton for SCI (WIP) (NCT07536386) | Clinical Trial Compass
RecruitingNot Applicable
Self-balancing Personal Exoskeleton for SCI (WIP)
France10 participantsStarted 2026-02-10
Plain-language summary
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
Who can participate
Age range18 Years
SexALL
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User inclusion criteria:
* Any gender, age 18 years or older
* Motor complete or incomplete SCI at any level
* ≥ 6 months post SCI
* Able and willing to attend 9 visits to the center, including sessions of training and assessments of one-to-three hours duration
* Able to read, understand, and provide informed consent.
* Patients affiliated to a social security system.
User exclusion criteria:
* Diagnosis of neurological injury other than SCI;
* Progressive condition that would be expected to result in changing neurological status;
* Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician;
* Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking;
* Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
* Untreatable severe spasticity judged to be contraindicated by the site physician;
* Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician;
* Unresolved orthostatic hypotension (change from baseline seated BP to a fall in 20mmHg SBP and/or fall in 10mmHG DBP and symptoms when standing), or as judged to be contraindicated by the site physician;
* Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton;
* Morphological contraindications to the use of the d…
What they're measuring
1
Safety of the device for its intended use and user population.
Timeframe: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.