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

NCT04453943 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-01

No results posted yet for this study

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

Interventions

DEVICE

Exoskeleton Walking - with or without FES

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.

DEVICE

Exoskeleton Sitting to Standing - with or without FES

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.

Sponsors & Collaborators

  • U.S. National Science Foundation

    collaborator FED
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • North Carolina State University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-01-01
Completion
2023-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04453943 on ClinicalTrials.gov