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Self-balancing Personal Exoskeleton for Spinal Cord Injury (WINY)

This study is testing a new self-balancing, hands-free exoskeleton called WINY for people with spinal cord injury (SCI), including those with paraplegia and tetraplegia. The goal is to see if the device is safe and effective for daily activities. You might be able to join if you are 18 or older, have had an SCI for at least 6 months, and can attend 9 to 10 visits to the study center in the US. The study will involve training sessions with the exoskeleton and assessments to see how well it works. The main thing researchers are looking at is the safety of the device throughout the study, which includes about 9 hours of training and 3 hours of assessment.

Study design
This is an interventional study, meaning you will receive a specific treatment. It plans to enroll up to 12 individuals with SCI and their companions.
What's involved
You would attend 9 to 10 visits to the center over 3 to 4 weeks, each lasting about 1.5 hours. These visits include screening, device fitting, training sessions, and assessments.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.

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NCT07222033

Self-balancing Personal Exoskeleton for SCI (WINY)

Recruiting
NAAges 18+Interventional
Wandercraft
~12 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
Safety of the device for its intended use and user population.
Measured over Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.

Conditions

Spinal Cord Injury
Paraplegia and Tetraplegia

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New York1

Who to contact

Joshua Breighner, PT DPT
[email protected]
646-448-4787
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

  • Safety of the device for its intended use and user population.Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.

    Collection and analysis of adverse events to evaluate the safety of the device for its intended use and user population, specifically for individuals with spinal cord injury (SCI) performing ambulatory activities hands-free, accompanied by a companion.