ExoAtlet II Lower Extremity Exoskeleton Safety and Efficacy Use With Spinal Cord Injured Individuals
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- ExoAtlet
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, to stand up and ambulate under a variety of conditions.
Detailed Description
The study will introduce the ExoAtlet II exoskeleton to SCI patients with lower extremity paralysis (partial or complete) and provide rehabilitative standing and walking intervention. The study will be conducted with a trained clinician that will fit each patient into the adjustable exoskeleton system and provide customized programming to meet each user's specific needs. The training program will be initiated based upon each patient's comfort in the exoskeleton and ability to stand with assistance. Each patient will be closely monitored to assess ongoing health as well as their individual standing and walking ability. All exoskeleton sessions will be performed with a trained medical professional controlling the exoskeleton. Patient safety is the primary concern and all adverse events will be documented and addressed. This study will evaluate the ExoAtlet 2.0 exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, the ability to stand up and walk in a clinical facility.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 Years of age or older in general good health
- •Weight, no more than 220lbs (100kg)
- •Skin must be healthy where it touches the ExoAtlet 2.0
- •Able to stand using a device such as a standing frame
- •Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
- •Have good control of upper body
- •Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
- •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 or C7 ASIA D
- •Severe muscle stiffness/tightness
- •Significant spasticity (Modified Ashworth Scale score of 3 or above)
- •Trunk or lower extremity pressure ulcer
- •Open Wounds/tissue hypersensitivity
- •Unstable spine, un-healed limbs, or fractures
- •Severe sensitivity to touch
- •Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints
- •Joint instability, dislocation, moderate to severe hip dysplasia
- •Significant scoliosis (\>40 degrees)
Outcomes
Primary Outcomes
Number of adverse events
Time Frame: 0-8 weeks
Document and track any adverse events, both minor and major, during exoskeleton sessions.
Skin integrity
Time Frame: 0-8 weeks
A visual inspection of the participant's skin, at all areas of contact with the exoskeleton, will be conducted at the beginning and end of each session.
Secondary Outcomes
- 10 Meter Walk Test(1 Day)
- Transfer in and out(2 Days)
- 6 Minute Walk Test(1 Day)
- Perform Sit to Stand to Sit(2 Days)