Self-balancing Personal Exoskeleton for Spinal Cord Injury

This study is testing a new self-balancing, hands-free exoskeleton called the Atalante X, developed by Wandercraft. It aims to see if this device is safe and effective for people with spinal cord injuries (SCI), including paraplegia and tetraplegia. You might be able to join if you are 18 or older, have had an SCI for at least 6 months, and live in the US. The study will measure success by seeing how many participants can complete a Timed Up and Go (TUG) test in 3 minutes or less, and walk at least 40 meters in a Six-Minute Walk Test (6MWT) after training. The current recruitment status is unclear.

Study design
This is an interventional study with a single group, meaning all participants will receive the exoskeleton training. It is open-label, so both you and the study team will know you are receiving the intervention. The study plans to enroll 24 participants.
What's involved
You would attend 9 to 10 visits to the study center over 3 to 4 weeks, each lasting 1 to 3 hours. These visits include screening, device fitting, five training sessions, and assessments.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at visit 7 (after about 7.5 hours of training) and visit 9 (after about 9 hours of training).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06814015

Self-balancing Personal Exoskeleton for SCI (Site 2)

Recruiting
NAAges 18+Interventional
Wandercraft
~24 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:Hands-free exoskeleton

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.
Measured over At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
+1 more outcome measured
Spinal Cord Injuries (SCI)
Paraplegia and Tetraplegia
1 sites across 1 states
New Jersey1
Leighann Martinez, Research Manager
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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;
Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance).
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.
  • Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

    The TUG evaluates the time from starting in a seated position to stand-up, walk 3 meters, turn around, walk back 3 meters and sit down on indoor surface.

  • Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

    The 6MWT measures the distance in meters traversed over 6 min, on indoor surface.