Self-balancing Personal Exoskeleton for SCI (site 2)

Description

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

Conditions

Spinal Cord Injuries (SCI), Paraplegia and Tetraplegia

Study Overview

Study Details

Study overview

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

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

Self-balancing Personal Exoskeleton for SCI (site 2)

Condition
Spinal Cord Injuries (SCI)
Intervention / Treatment

-

Contacts and Locations

West Orange

Kessler Foundation, West Orange, New Jersey, United States, 07052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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;
  • * Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wandercraft,

Study Record Dates

2025-05-31