Hands-free exoskeleton for spinal cord injury patients

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

This study is testing a hands-free exoskeleton to see if it can help people with spinal cord injuries move better and feel more stable in their daily lives.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wandercraft (Industry-sponsored)
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT06777576 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a personal exoskeleton designed for individuals with spinal cord injuries (SCI). The exoskeleton, developed by Wandercraft, features a hands-free and self-balancing design aimed at improving stability and mobility in daily activities. Participants will undergo a series of training sessions and assessments over a period of 3 to 4 weeks at two research facilities in the US. The study will enroll 29 participants to account for potential dropouts, with a focus on ensuring competency in using the device.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with motor complete or incomplete SCI at or above T6, who are at least 6 months post-injury.

Not a fit: Patients with neurological injuries other than SCI or those with severe concurrent medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this exoskeleton could significantly enhance mobility and independence for individuals with spinal cord injuries.

How similar studies have performed: Other studies have shown promise with robotic exoskeletons for rehabilitation, but this specific hands-free design is relatively novel.

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

The Bronx, New York

• James J. Peters, VA Medical Center, Bronx, NY — The Bronx, New York, United States (Recruiting)

Study contacts

• Study coordinator: Ann M Spungen, EdD

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