Clinical trial NCT04532723: Exoskeleton-Assisted Walking ExoAtlet II
Official title: Exoskeleton-Assisted Walking ExoAtlet II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: COSMO ROBOTICS CO., Ltd
First posted: 2020-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Skin Integrity
timeFrame: change from baseline skin integrity at 2 weeks
measure: Change in Falls
timeFrame: change from baseline number of falls at 2 weeks
measure: Change in Fractures
timeFrame: change from baseline number of fractures at 2 weeks
Secondary outcomes:
measure: Heart Rate
timeFrame: Baseline, Week 1
measure: Blood pressure
timeFrame: Baseline, Week 1
measure: Spasticity
timeFrame: Baseline, Week 1, Week 2
measure: Standing Time
timeFrame: Baseline, Week 1
measure: Ambulation Time
timeFrame: Week 1
measure: Standing Assistance
timeFrame: Baseline, Week 1
measure: Ambulation Assistance
timeFrame: Week 1
measure: 6 Minute Walk Test
timeFrame: Week 1
measure: 10 Meter Walk Test
timeFrame: Week 1
measure: Physical Activity Enjoyment Scale
timeFrame: Baseline, Week 1, Week 2
measure: BORG Rate of Perceived Exertion
timeFrame: Baseline, Week 1
Other outcomes:
Locations:
Study officials:
References: