RECRUITING

Self-balancing Personal Exoskeleton for SCI (site 2)

Conditions

Spinal Cord Injuries (SCI)Paraplegia and Tetraplegia Spinal Cord Injury Robotics Community use Hands-free exoskeleton Overground exoskeleton Walking Self-balancing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-25

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06814015

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Leighann Martinez, Research Manager

CONTACT

973-324-3557

lmartinez@kesslerfoundation.org

Michelle Agostini, Doctorate of Physical Therapy

CONTACT

Magostini@Kesslerfoundation.org

Study Locations (Sites)

Kessler Foundation

West Orange, New Jersey, 07052

United States

Collaborators and Investigators

Sponsor: Wandercraft

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2025-02-25

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

Spinal Cord Injury
Robotics
Community use
Hands-free exoskeleton
Overground exoskeleton
Walking
Self-balancing

Additional Relevant MeSH Terms

Spinal Cord Injuries (SCI)
Paraplegia and Tetraplegia