Hands-free self-balancing personal exoskeleton for people with spinal cord injury

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

Researchers will test a hands-free, self-balancing exoskeleton to see if it can safely help adults with spinal cord injury stand, walk, and move in daily life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wandercraft (Industry-sponsored)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07222033 on ClinicalTrials.gov

What this trial studies

This open-label, single-group prospective study will enroll up to 12 adults with spinal cord injury and their companions at a single U.S. site over about 3–4 weeks. Participants will be fitted with Wandercraft's new version of the Atalante X, a self‑balancing, hands‑free overground exoskeleton, and will complete nine to ten in-person visits including screening, device fitting, five structured training sessions, two effectiveness evaluations, and one extra practice session. Training culminates in a competency certificate confirming participants can perform the device's basic skills, and each visit lasts about 1.5 hours. The study collects safety, feasibility, and functional mobility outcomes relevant to community and daily activities.

Who should consider this trial

Good fit: Ideal candidates are English-speaking U.S. residents aged 18 or older with motor complete or incomplete SCI at or above T6 who are at least six months post-injury and can attend 9–10 in-person visits and provide informed consent.

Not a fit: People with non-SCI neurological diagnoses, progressive neurological conditions, severe medical comorbidities, unhealed or unstable high-impact lower extremity fractures, or low bone density below the study's thresholds are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could improve independent standing and overground mobility and make daily activities easier for some people with spinal cord injury.

How similar studies have performed: Previous wearable exoskeleton programs have shown improved standing and overground ambulation in some people with SCI, but fully hands-free, self‑balancing devices like this are newer and have more limited clinical data.

Eligibility criteria

SCI user inclusion Criteria:

* Any gender, age 18 years or older;
* Motor complete or incomplete SCI with lesions at or above T6;
* ≥ 6 months post SCI;
* Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration;
* Able to read, understand, and provide informed consent;
* Living in the US and speaks English.

SCI 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;
* Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2;
* Total hip BMD T-scores \< -3.5;
* Fragility, minimal trauma, or low impact fracture of the lower extremity since SCI;
* 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 hand-control interface, 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 hand control interface.
* 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;
* History of uncontrolled autonomic dysreflexia;
* Presence colostomy and/or urostomy;
* Ventilator use at the time of the exoskeleton use;

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;
* Living in the US and speaks English.

Companion exclusion Criteria:

* Inability to communicate with an assistant 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

New York, New York

• Walk in New York (WINY) Physical Therapy, P.C. — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Joshua Breighner, PT DPT

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