Exoskeleton-Assisted Walking ExoAtlet II

Study Overview
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Brief Summary
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Based on prior exoskeleton research, it was determined that 40 participants of variable height, weight and injury level would provide a significant measure of the safety and feasibility of using the ExoAtlet II in individuals with SCI for standing and walking rehabilitation therapy. Craig Hospital will be responsible for enrolling up to 30 individuals during the study duration.The inclusion criteria will be utilized to identify appropriate subjects for this study.

Official Title
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Exoskeleton-Assisted Walking ExoAtlet II

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: ExoAtlet II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal Cord injury with lower extremity paralysis (partial or complete) levels T4-L5 (AIS A-C) or C7-T3 (AIS D) 18 Years of age or older in general good health Weight, no more than 220lbs (100kg) Intact Skin Able to stand without exhibiting symptomatic hypotension Use a wheelchair for mobility at least 50% of the day Enough strength in hands and shoulders to support standing and walking using crutches or a walker Medical clearance for full weight-bearing ---Per our clinical guidelines, we will require all individuals with SCI who are going to use an exoskeleton to receive full weight-bearing medical clearance from their physician prior to participation. If they are unable to obtain full weight-bearing medical clearance they will not be able to participate in this study. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid Hip width no greater than 18 (46 cm) measured when sitting Femur length between 37 cm and 49 cm measured between mid-patellar tendon and the floor Exclusion Criteria: Spinal cord injury level higher than T4 (AIS A-C) or C7 ASIA D Severe muscle stiffness/tightness Significant spasticity (Modified Ashworth Scale score of 3 or above) Trunk or lower extremity pressure wound Unstable spine, un-healed limbs, or fractures Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints ---Each individual who is interested in participating in this study will be screened for heterotropic ossification (HO) using a verbal checklist first and then they participate in a thorough range of motion (ROM) evaluation before being fit in the exoskeleton. If they verbalize a history of HO or demonstrate a bony block/resistance to passive ROM, they will be sent back to their physician to rule out HO and will not participate in the study until they receive additional clearance. Joint instability, dislocation, moderate to severe hip dysplasia Uncontrolled seizures Fracture or lower-limb surgery in past year Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton Pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExoAtlet II<br>Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI | Device: ExoAtlet II<br>* ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin Integrity | Skin breakdown | change from baseline skin integrity at 2 weeks | 
| Change in Falls | Number of falls | change from baseline number of falls at 2 weeks | 
| Change in Fractures | Number of fractures and cause | change from baseline number of fractures at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart rate beats per minute | Baseline, Week 1 | 
| Blood pressure | Blood pressures mm/Hg | Baseline, Week 1 | 
| Spasticity | Modified Ashworth | Baseline, Week 1, Week 2 | 
| Standing Time | Upright and weight bearing total time | Baseline, Week 1 | 
| Ambulation Time | Total walking time | Week 1 | 
| Standing Assistance | level of assistance in standing | Baseline, Week 1 | 
| Ambulation Assistance | Level of assistance for walking | Week 1 | 
| 6 Minute Walk Test | Total distance walked in 6 minutes | Week 1 | 
| 10 Meter Walk Test | total time to walk 10 meters | Week 1 | 
| Physical Activity Enjoyment Scale | Scale of participant enjoyment in the moment. 7-point bipolar rating scale, eleven items are reverse scored. Higher total score reflect greater levels of enjoyment | Baseline, Week 1, Week 2 | 
| BORG Rate of Perceived Exertion | Scale of participant effort. Lowest score is 6 and 20 is highest score. Higher scores reflect greater effort exerted by participant | Baseline, Week 1 |