Exoskeleton-Assisted Walking ExoAtlet II

Spinal Cord Injuries Clinical Trial

Official title:

Exoskeleton-Assisted Walking ExoAtlet II

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04532723
• Other study ID #: IRBNet ID 1559813
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: October 2023

Study information

• Verified date: August 2021
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• ExoAtlet II
ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Craig Hospital	ExoAtlet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Integrity	Skin breakdown	change from baseline skin integrity at 2 weeks
Primary	Change in Falls	Number of falls	change from baseline number of falls at 2 weeks
Primary	Change in Fractures	Number of fractures and cause	change from baseline number of fractures at 2 weeks
Secondary	Heart Rate	Heart rate beats per minute	Baseline, Week 1
Secondary	Blood pressure	Blood pressures mm/Hg	Baseline, Week 1
Secondary	Spasticity	Modified Ashworth	Baseline, Week 1, Week 2
Secondary	Standing Time	Upright and weight bearing total time	Baseline, Week 1
Secondary	Ambulation Time	Total walking time	Week 1
Secondary	Standing Assistance	level of assistance in standing	Baseline, Week 1
Secondary	Ambulation Assistance	Level of assistance for walking	Week 1
Secondary	6 Minute Walk Test	Total distance walked in 6 minutes	Week 1
Secondary	10 Meter Walk Test	total time to walk 10 meters	Week 1
Secondary	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
Secondary	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