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Self-balancing Exoskeleton for Spinal Cord Injury

This study is testing a new hands-free, self-balancing exoskeleton called Atalante X, developed by Wandercraft, for people with spinal cord injuries (SCI). The goal is to see if it's safe and effective at improving stability and movement for daily activities. You might be able to join if you are 18 or older, have an SCI (paraplegia or tetraplegia) that happened at least 6 months ago, and live in the US and speak English. The study will measure how many participants can complete a walking test (Timed Up and Go) in 3 minutes or less, and walk at least 40 meters (Six-Minute Walk Test) after training. The current recruitment status is unclear.

Study design
This is an interventional study with one group of participants, aiming to enroll 29 people. It is an open-label study, meaning both you and the researchers will know you are receiving the exoskeleton.
What's involved
You would attend 9 to 10 visits over 3 to 4 weeks, each lasting about 1.5 hours. These visits include screening, device fitting, five training sessions, and two sessions to evaluate the exoskeleton's effectiveness.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured after an average of 7.5 hours and 9 hours of training, at visits 7 and 9.

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

NCT06777576

Self-balancing Personal Exoskeleton for SCI

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

Conditions

Spinal Cord Injuries (SCI)
Paraplegia and Tetraplegia

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New York1

Who to contact

Ann M Spungen, EdD
[email protected]
718-584-9000 · ext. 5814
Email the study team

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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.
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.

What this trial measures

  • 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.