Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury

NCT ID: NCT07128901

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-01

Brief Summary

The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.

Detailed Description

Although Lower Limb Exoskeleton technology holds promise for improving mobility and independence in people with Spinal Cord Injury, limited research has examined the physiological and psychological effects of walking with self-balancing lower limb exoskeleton technology compared to systems that require user-operated assistive aids. Moreover, no studies to date have directly compared the short- and long-term outcomes of two lower limb exoskeleton technology types: (1) self-balancing and (2) user-balancing. To address this gap, this study will conduct a head-to-head comparison of self-balancing and user-balancing lower limb exoskeleton technology in individuals with motor-complete (ASIA Impairment Scale Classification [AIS] A/B) Spinal Cord Injury-a population that remains underrepresented in rehabilitation robotics research despite advances in the field.

Study participants will complete 5 walking sessions and 2 test sessions with two different exoskeleton devices in a randomized order. During each test session, data will be collected using motion sensors, portable metabolic monitors, and muscle sensors.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Self-balancing lower limb exoskeleton

Participants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.

Group Type: EXPERIMENTAL

Wandercraft Atalante X

Intervention Type: DEVICE

Self-balancing lower limb exoskeleton

User-balancing lower limb exoskeleton

Participants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.

Group Type: EXPERIMENTAL

Ekso Indego Therapy

Intervention Type: DEVICE

User-balancing lower Limb exoskeleton

Interventions

Ekso Indego Therapy

User-balancing lower Limb exoskeleton

Intervention Type: DEVICE

Wandercraft Atalante X

Self-balancing lower limb exoskeleton

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subacute to chronic SCI (≥ 3mths post injury)
• Motor-complete (ASIA Impairment Scale classification A/B)
• Injury level T3-T10
• Age 18-70 yrs
• Height between 5'1" and 6'1"
• Weight <200 lbs (90kg)
• Seated hip width < 42cm
• Standing tolerance > 15mins
• Have sufficient upper limb strength to use a platform rolling walker, rolling walker, or forearm crutches
• Currently medically cleared and enrolled in the Shepherd Center Beyond Therapy program
• Medically cleared for weight-bearing activities
• Able to follow directions to safely participate in assessments

Exclusion Criteria

• Existing skin lesions or wounds
• Hip or knee contracture > 10 degrees or ankle contracture > 5 degrees
• Severe or uncontrolled spasticity
• Non-healing fractures
• Uncontrolled autonomic dysreflexia
• Heart or peripheral vascular condition
• Pregnancy
• Active heterotopic ossification
• Active deep vein thrombosis
• Cognitive deficits that make it difficult for participants to follow verbal instructions or making it unsafe to participate in assessments.
• Any reason the principal investigator feels the potential participant may not be safe to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: collaborator

Georgia Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Maegan Tucker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Shepherd Center

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Maegan Tucker, PhD

Role: CONTACT

mtucker@gatech.edu

617-417-4211

Nick Evans, PhD

Role: CONTACT

nicholas.evans@shepherd.org

Facility Contacts

Maegan Tucker, PhD

Role: primary

mtucker@gatech.edu

6174174211

Other Identifiers

2331046-1

Identifier Type: -

Identifier Source: org_study_id