Self-balancing Personal Exoskeleton for SCI

NCT06777576 | Recruiting FDA Device

• 1 other identifier: CIP007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.

  The TUG evaluates the time from starting in a seated position to stand-up, walk 3 meters, turn around, walk back 3 meters and sit down on indoor surface.

  At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

• Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).

  The 6MWT measures the distance in meters traversed over 6 min, on indoor surface.

  At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

Secondary Outcomes (3)

• Proportion of subjects who can complete at least 4 out of the 6 Activities of Daily Living (ADLs), in various simulated environments and with the exoskeleton.

  At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

• Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less.

  At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

• Proportion of subjects who can don or doff the device within 10 minutes each, separately.

  At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

Other Outcomes (10)

• Proportion of users who pass the device "basic skills" certification evaluation at the end of visit 6.

  Throughout the study and up until the end of Visit 6, after an average of 7.5 hours of training.

• Number of users who successfully master the different basic skills at a given visit

  Throughout the study and up until the end of Visit 6, after an average of 7.5 hours of training.

• Evaluation of the assistance level provided by companion.

  Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.

Study Arms (1)

Hands-free exoskeleton

EXPERIMENTAL

Device: Hands-free exoskeleton

Interventions

Hands-free exoskeleton DEVICE

A "device trainer specialist" from the investigation site will deliver training sessions with the exoskeleton to pair of participants (a pair corresponds to an individual with SCI and his/her companion). The device trainer will follow the progression of the pair through the training program and ensure they learn all the device "basic skills". Each training session lasts an average of 1.5 hours, variations according to the user's learning pace and tolerance. During the sessions with the exoskeleton, the participants will engage in mobility activities on different surfaces and perform Activities of Daily Living in simulated environments such as kitchen, bathroom, elevators and outdoor spaces.

Hands-free exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Wandercraft: lead
• James J. Peters Veterans Affairs Medical Center: collaborator

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ann M Spungen, EdD

CONTACT

718-584-9000; ann.spungen@va.gov

David Kim

CONTACT

718-584-9000; david.kim12@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 16, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)