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

NCT07128901 | Recruiting FDA Device

• 1 other identifier: 2331046-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

lower limb exoskeleton

Outcome Measures

Primary Outcomes (2)

• 10 meter walk test (10MWT)

  This will be measured as the participant walks a distance of 10 meters at their self-selected (or comfortable) walking speed. Three 10-meter walk trials will be completed by each participant at each time point. The average of three 10MWT walking speeds will be analyzed and reported. This measure will be recorded in seconds and converted to meters/s with higher values indicating faster speed and lower values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.

  1 year

• 6 minute walk test (6MWT)

  This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance (meters) over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.

  1 year

Secondary Outcomes (5)

• Neuromuscular activation of specified muscles

  1 year

• Walking economy

  1 year

• Rating of Perceived Exertion

  1 year

• Total hemoglobin concentration

  1 year

• User-experience survey

  1 year

Study Arms (2)

Self-balancing lower limb exoskeleton

EXPERIMENTAL

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

Device: Wandercraft Atalante X

User-balancing lower limb exoskeleton

EXPERIMENTAL

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

Device: Ekso Indego Therapy

Interventions

Ekso Indego Therapy DEVICE

User-balancing lower Limb exoskeleton

User-balancing lower limb exoskeleton

Wandercraft Atalante X DEVICE

Self-balancing lower limb exoskeleton

Self-balancing lower limb exoskeleton

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subacute to chronic SCI (≥ 3mths post injury)
• Motor-complete (ASIA Impairment Scale classification A/B)
• Injury level T3-T11
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: collaborator
• Georgia Institute of Technology: lead

Study Sites (1)

The Shepherd Center

Atlanta, Georgia, 30332, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Maegan Tucker, PhD

CONTACT

617-417-4211; mtucker@gatech.edu

Nick Evans, PhD

CONTACT

nicholas.evans@shepherd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 19, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)