Status:
UNKNOWN
Modeling, Optimization, and Control Methods for a Personalized Hybrid Walking Exoskeleton
Lead Sponsor:
North Carolina State University
Collaborating Sponsors:
U.S. National Science Foundation
University of North Carolina, Chapel Hill
Conditions:
Spinal Cord Injuries
Paraplegia, Spinal
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The central objective of this study is to validate new algorithms that coordinate between functional electrical stimulation (FES) and the exoskeleton during sitting-to-standing, walking, and standing-...
Detailed Description
Research activities involve use of computer-controlled functional electrical stimulation (FES) and electric motor-driven orthosis (powered exoskeleton) to generate functional lower-limb movements for;...
Eligibility Criteria
Inclusion
- Inclusion criteria for persons with SCI:
- Participants will be men and women age 18-60 and have a primary diagnosis of complete or incomplete spinal cord injury, weigh less than 220 pounds (100kg), free from acute illness, and be at least 1 year post injury.
- Individuals with injury between T-1 and T-10 level will be recruited (injury level for each participant will be assessed by a therapist on ASIA scale).
- Medically stable with medical clearance for participation, no evidence of cardiopulmonary or pulmonary disease, severe spasticity, asymmetric hip positions.
- Individuals who regularly bear weight bear during transfers (either with or without braces) so that we are using people who are accustomed to bearing weight on their lower limbs
- The subjects who have experience in using some kind of walking assistive devices in the past or recently will be recruited.
- Subjects must have at least one lower limb muscle group respond to FES.
- Inclusion criteria for persons without SCI:
- Subjects will be included if they are between the ages of 18 and 60 and weigh less than 220 lbs (100kg).
- Healthy, are able to walk normally, are able to sit patiently for 4 hours.
- People who pass an assessment of safety by Dr. Cleveland. This would be a screen done by Dr. Cleveland after consent to determine if person is eligible. The proposed research will exclude children and pregnant women. We first aim to collect research data from adults as the proposed methods in the study have not been investigated on children and pregnant women.
- Exclusion criteria for persons with SCI:
- Subjects with other neuromuscular disease such as polio, stroke or multiple sclerosis.
- Persons with heart conditions and pacemakers will be excluded.
- Concurrent severe medical disease, pressure sores, open wounds, existing infection, unstable spine, unhealed limb or pelvic fractures, history of recurrent fractures, known orthopedic injury to lower extremities, and osteoporosis.
- Subjects with SCI who have open wounds, weight if with weight exceeds more than 220lb (100kg)
- Subjects with SCI with insufficient knee or hip range of motion, i.e. contractures will be excluded. If someone has contractures it may not be possible, or safe, for them to be in the device. Persons who do not have following minimum joint angle range of motion: knee flexion from 0-80°, hip flexion from 0-45° and hip extension 0-10° will be excluded.
- Subjects who find FES uncomfortable or painful; particularly, FES of the quadriceps muscle, hamstrings muscle, and ankle muscles.
- Exclusion criteria for persons without SCI: 1. A history of a neurological or an orthopedic disease that hampers normal lower limb movement 2. Persons with heart conditions and pacemakers will be excluded. 3. Any difficulty or an orthopedic condition that would impede knee extension 4. Absent sensation in lower leg 5. Subjects who find FES uncomfortable or painful; particularly, FES of the quadriceps muscle, hamstrings muscle, and ankle muscles.
Exclusion
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04453943
Start Date
July 1 2020
End Date
January 1 2023
Last Update
July 1 2020
Active Locations (1)
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1
4212C Engineering Building III 1840 Entrepreneur Dr.
Raleigh, North Carolina, United States, 27695