Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06777576

Self-balancing Personal Exoskeleton for SCI

Led by Wandercraft · Updated on 2026-02-02

24

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

Sponsors

W

Wandercraft

Lead Sponsor

J

James J. Peters Veterans Affairs Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

CONDITIONS

Official Title

Self-balancing Personal Exoskeleton for SCI

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any gender, age 18 years or older
  • Motor complete or incomplete spinal cord injury with lesions at or above T6
  • At least 6 months post spinal cord injury
  • Able and willing to attend 9 to 10 visits, including training and assessments lasting 1 to 3 hours
  • Able to read, understand, and provide informed consent
  • Living in the US and speaks English
Not Eligible

You will not qualify if you...

  • Diagnosis of neurological injury other than spinal cord injury
  • Progressive condition expected to change neurological status
  • Severe concurrent medical disease or illness contraindicated by the study physician
  • Unhealed or unstable traumatic or high impact lower extremity fracture
  • Knee bone mineral density less than 0.60 gm/cm2
  • Total hip bone mineral density T-scores less than -3.5
  • Fragility, minimal trauma, or low impact fracture of the lower extremity since spinal cord injury
  • Untreatable severe spasticity contraindicated by the study physician
  • Untreated or uncontrolled hypertension contraindicated by the study physician
  • Unresolved orthostatic hypotension or contraindicated by the study physician
  • Open or unhealed skin pressure sores, abrasions, or bruises at exoskeleton contact points
  • Morphological contraindications to exoskeleton use
  • Uncorrectable leg length discrepancy over 2 cm even with correction tools
  • Unable to operate the device hand-control interface effectively due to functional or cognitive impairment
  • Improper fitting in the device
  • Psychopathology that may conflict with study objectives
  • Pregnancy or planning pregnancy during the study
  • Concurrent participation in another interventional trial
  • History of uncontrolled autonomic dysreflexia
  • Presence of colostomy and/or urostomy
  • Use of a ventilator at time of exoskeleton use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

James J. Peters, VA Medical Center, Bronx, NY

The Bronx, New York, United States, 10468-3904

Actively Recruiting

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Research Team

A

Ann M Spungen, EdD

CONTACT

D

David Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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