Exoskeleton-Assisted Walking ExoAtlet II

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: ExoAtlet II

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ExoAtlet II; Safety/feasibility of utilizing the ExoAtlet II in a clinical setting with a group of individuals with SCI	Device: ExoAtlet II; ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: ExoAtlet

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: IRBNet ID 1559813

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No