NCT06777576 · Wandercraft
Self-balancing Personal Exoskeleton for SCI
What this study is about
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
View original scientific description
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- The Bronx, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations