- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453943
Modeling, Optimization, and Control Methods for a Personalized Hybrid Walking Exoskeleton
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27695
- 4212C Engineering Building III 1840 Entrepreneur Dr.
-
Contact:
- Nitin Sharma, Ph.D.
- Email: nsharm23@ncsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A - SCI
Ten individuals with SCI at the T1-T10 level will be recruited (Group A).
These individuals can have incomplete or complete paraplegia.
|
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.
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.
|
EXPERIMENTAL: Group B - Subjects without disability
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Controls Algorithm Performance - Limb Angle Errors
Time Frame: Through study completion, an average of 30 months.
|
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
Time Frame: Through study completion, an average of 30 months.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Verbal Feedback
Time Frame: Through study completion, an average of 30 months.
|
We may ask the participant about their qualitative experience about the of our device and algorithms during the experiments.
|
Through study completion, an average of 30 months.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20553
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
Lineage Cell Therapeutics, Inc.CompletedCervical Spinal Cord Injury | Spine Injury | Spinal Cord TraumaUnited States
Clinical Trials on Exoskeleton Walking - with or without FES
-
Hospital Nacional de Parapléjicos de ToledoInstitut GuttmannCompletedSpinal Cord Injury | Incomplete Spinal Cord InjurySpain
-
Hasselt UniversityRevalidatie & MS Centrum OverpeltRecruiting
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCerebrovascular AccidentUnited States
-
Ludwig-Maximilians - University of MunichTherapiezentrum BurgauCompletedBrain Injuries | Disorders of ConsciousnessGermany
-
North Carolina State UniversityUniversity of North Carolina, Chapel HillRecruiting
-
Groupe Hospitalier Paris Saint JosephWithdrawnChronic Inflammatory Demyelinating Polyradiculoneuropathy
-
Samsung Medical CenterCompletedAgingKorea, Republic of
-
Fisher and Paykel HealthcareMedical Research Institute of New Zealand; Alana HealthcareTerminatedChronic Obstructive Pulmonary Disease | COPDUnited States, New Zealand
-
University of AarhusAarhus University Hospital SkejbyCompletedRespiratory Aspiration of Gastric Content
-
University Hospital, LinkoepingRecruiting