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

Georgia Institute of Technology

Status: Not yet enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: Ekso Indego Therapy; Device: Wandercraft Atalante X

Study type: Interventional

Funder types: Other

Identifiers

NCT07128901

2331046-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Self-balancing lower limb exoskeleton

Experimental group

Description:

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

Treatment:

Device: Wandercraft Atalante X

User-balancing lower limb exoskeleton

Experimental group

Description:

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

Treatment:

Device: Ekso Indego Therapy