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

Empowering Mobility in People With Spinal Cord Injury With a Hands-free, Self-balancing Personal Exoskeleton

This study will try a hands-free, self-balancing exoskeleton in adults with spinal cord injury to see if it safely helps with standing and walking in daily life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wandercraft (Industry-sponsored)
• Locations: 1 site (Paris)
• Trial ID: NCT07536386 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) at least six months after motor complete or incomplete spinal cord injury who are medically stable, able to attend multiple visits in Paris, and can provide informed consent are ideal candidates.

Not a fit: People with progressive neurological disorders, untreated severe spasticity, unstable or unhealed lower-limb fractures, significant osteoporosis, or other severe comorbidities are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, the device could enable some people with spinal cord injury to stand and walk more safely and independently in everyday settings.

How similar studies have performed: Powered exoskeletons have shown safety and improved mobility in several studies, but fully hands-free, self-balancing overground devices like this one are newer and less extensively tested.

Eligibility criteria

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 this trial is running

Paris

• Wandercraft — Paris, France (Recruiting)

Study contacts

• Study coordinator: Jeanne Vanmairis

Conditions Spinal Cord Injuries; Paraplegia and Tetraplegia; Spinal Cord Injury; Robotics; Community use; Hands-free exoskeleton; Overground exoskeleton; Walking