Hands-free self-balancing exoskeleton to help walking after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-group study tests a new hands-free, self-balancing personal exoskeleton (an updated Atalante X) in adults with spinal cord injury. Up to 10 participants (minimum 5) and their companions attend nine to ten visits over about two months at Wandercraft in Paris for device fitting, five training sessions culminating in a competency certificate for basic skills, two effectiveness evaluations, and one extra practice session. Each visit lasts about 1.5 hours and the protocol enrolls adults at least six months post-injury who are medically stable without contraindicating fractures, severe untreated spasticity, or osteoporosis. Outcomes focus on safety, device usability, and mobility-related effectiveness during overground, community-use scenarios.

Why it matters

Who can join: the full rules

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 device;
* Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools;
* Unable to effectively operate the device with a controller, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify buttons on the controller.
* Improper fitting in the device;
* Psychopathology documentation in the medical record that may conflict with study objectives;
* Pregnancy or women who plan to become pregnant during the study period;
* Concurrent participation in another interventional trial;
* Uncontrolled autonomic dysreflexia;
* Ventilator use at the time of the exoskeleton use.
* Patient under legal protection.

Companion inclusion criteria

* Any gender, age 18 years or older.
* Willingness to attend 9 to 10 visits to the center, including sessions of training and assessments of one-to-three hours duration with the SCI user.
* Able to read, understand and provide informed consent.

Companion exclusion criteria:

* Inability to communicate due to cognitive and language disorders;
* Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments;
* Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall;
* Insufficient availability to complete the study;
* Concurrent participation in another interventional trial.

Where it's running

• Wandercraft
  Paris, France Recruiting

Study contacts

• Study coordinator: Jeanne Vanmairis
• Email: walkinparis@wandercraft.health
• Phone: +33 (0)1 79 35 31 09

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.