Modeling, Optimization, and Control Methods for a Personalized Hybrid Walking Exoskeleton

NCT04453943 | Unknown FDA Device

• 1 other identifier: 20553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-to-sitting movements. The secondary objective is to optimize the algorithms as well as assess their ability to reduce FES-induced muscle fatigue by using ultrasound imaging as a sensing modality. This study will include persons with no disabilities and persons with Spinal Cord Injury (SCI). A research set-up comprising of a lower-limb exoskeleton and FES system will be used to achieve sitting-to-standing, walking, and standing-to-sitting movements. Ultrasound Imaging probes may be used to record muscle activity of the stimulated muscles. The signals derived from ultrasound will be used to optimize FES in order to reduce muscle fatigue as well as assess muscle fatigue.

Conditions

Spinal Cord Injuries; Paraplegia, Spinal; Paraplegia, Incomplete

Keywords

Rehabilitative Robotics; Exoskeleton; Hybrid Neuroprosthesis; Spinal Cord Injury; Functional Electrical Stimulation; Ultrasound; Muscular Fatigue

Outcome Measures

Primary Outcomes (2)

• Controls Algorithm Performance - Limb Angle Errors

  The computer-controlled algorithms will get feedback from sensors that are inbuilt in the neuroprosthesis (exoskeleton). A motion capture system may also be used to measure joint angles so that spatiotemporal gait characteristics can be compared with the normal gait of a healthy control subject. Ultrasound imaging can be used as a tool to measure muscle fatigue induced by FES. The performance of the controls algorithm and success of the movements generated will be evaluated after this data is collected.

  Through study completion, an average of 30 months.

• Muscle fatigue Index to Measure FES-Induced Muscle Fatigue

  The muscle fatigue index will be measured to assess muscle fatigue in a participant using the hybrid neuroprosthesis/exoskeleton.

  Through study completion, an average of 30 months.

Secondary Outcomes (1)

• Participant Verbal Feedback

  Through study completion, an average of 30 months.

Study Arms (2)

Group A - SCI

EXPERIMENTAL

Ten individuals with SCI at the T1-T10 level will be recruited (Group A). These individuals can have incomplete or complete paraplegia.

Device: Exoskeleton Walking - with or without FES; Device: Exoskeleton Sitting to Standing - with or without FES

Group B - Subjects without disability

EXPERIMENTAL

Twenty individuals without disability will be recruited (Group B). Individuals with SCI who have experience in using some kind of walking assistive devices in the recent past will be preferably recruited.

Device: Exoskeleton Walking - with or without FES; Device: Exoskeleton Sitting to Standing - with or without FES

Interventions

Exoskeleton Walking - with or without FES DEVICE

The study involves validation of computer algorithms to estimate and control walking movements. The Rifton E-Pacer motorized walker, arm crutches, parallel bars, or a conventional walker may be used in order to assist donning and doffing of the exoskeleton system, standing, and walking for all subjects, at any time during experimentation. Walking movements will be elicited by the hybrid walking platform that combines a powered exoskeleton and an FES system. The powered exoskeleton can provide joint actuation at the hip and knee joints of a participant. The FES system can stimulate the quadriceps, hamstrings muscle, glutes, and ankle muscles.

Group A - SCI; Group B - Subjects without disability

Exoskeleton Sitting to Standing - with or without FES DEVICE

The study involves validation of computer algorithms to estimate and control sitting/standing movements. The Rifton E-Pacer motorized walker, arm crutches, parallel bars, or a conventional walker may be used in order to assist donning and doffing of the exoskeleton system, standing, and walking for all subjects, at any time during experimentation. Sitting/Standing movements will be elicited by the hybrid walking platform that combines a powered exoskeleton and an FES system. The powered exoskeleton can provide joint actuation at the hip and knee joints of a participant. The FES system can stimulate the quadriceps, hamstrings muscle, glutes, and ankle muscles.

Group A - SCI; Group B - Subjects without disability

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Carolina State University: lead
• U.S. National Science Foundation: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

4212C Engineering Building III 1840 Entrepreneur Dr.

Raleigh, North Carolina, 27695, United States

Location

Related Publications (5)

• Bao X, Kirsch N, Dodson A, Sharma N. Model Predictive Control of a Feedback-Linearized Hybrid Neuroprosthetic System With a Barrier Penalty. J Comput Nonlinear Dyn. 2019 Oct 1;14(10):101009-1010097. doi: 10.1115/1.4042903. Epub 2019 Sep 9.

  PMID: 32280315 BACKGROUND

• Kirsch NA, Bao X, Alibeji NA, Dicianno BE, Sharma N. Model-Based Dynamic Control Allocation in a Hybrid Neuroprosthesis. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):224-232. doi: 10.1109/TNSRE.2017.2756023. Epub 2017 Sep 22.

  PMID: 28952946 BACKGROUND

• Alibeji NA, Molazadeh V, Dicianno BE, Sharma N. A Control Scheme That Uses Dynamic Postural Synergies to Coordinate a Hybrid Walking Neuroprosthesis: Theory and Experiments. Front Neurosci. 2018 Apr 10;12:159. doi: 10.3389/fnins.2018.00159. eCollection 2018.

  PMID: 29692699 BACKGROUND

• Alibeji NA, Kirsch NA, Sharma N. A Muscle Synergy-Inspired Adaptive Control Scheme for a Hybrid Walking Neuroprosthesis. Front Bioeng Biotechnol. 2015 Dec 21;3:203. doi: 10.3389/fbioe.2015.00203. eCollection 2015.

  PMID: 26734606 BACKGROUND

• Kirsch N, Alibeji N, Fisher L, Gregory C, Sharma N. A semi-active hybrid neuroprosthesis for restoring lower limb function in paraplegics. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:2557-60. doi: 10.1109/EMBC.2014.6944144.

  PMID: 25570512 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nitin Sharma, Ph.D.

CONTACT

919-513-0787; nsharm23@ncsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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-to-sitting movements. The secondary objective is to optimize the algorithms as well as assess their ability to reduce FES-induced muscle fatigue by using ultrasound imaging as a sensing modality. This study is performed with two sets of subjects: people with spinal cord injury and people without disability.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)