Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
Study Overview
Status
Conditions
Detailed Description
The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology.
The primary objective of this study is to evaluate the safety, feasibility, and efficacy of using the forearm ExoNET. Specifically, investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion. To accomplish this, we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET. To achieve these goals, we will use a wearable surface electromyography (EMG) and inertial measurement unit (IMU) using Delsys wearable sensors on the forearm muscles.
Investigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test (ARAT) measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support. Secondarily, investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke. Lastly, it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe, feasible and tolerated by patients in a given treatment session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Courtney Celian, MSOT
- Phone Number: 312-238-1560
- Email: ccelian@sralab.org
Study Contact Backup
- Name: Valentino I Wilson
- Phone Number: 630-398-2355
- Email: viwilso2@uic.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60610
- Recruiting
- Shirley Ryan Abilitylab
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Principal Investigator:
- James Patton, PhD
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Sub-Investigator:
- Valentino I Wilson, MEng
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Contact:
- Courtney Celian, OTR/L
- Phone Number: 312-238-1560
- Email: ccelian@sralab.org
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Sub-Investigator:
- Courtney Celian, OTR/L
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
- Have sustained a single, unilateral stroke at least 8 months prior to enrollment
- Severe to moderate upper extremity impairment (ARAT score 0-30)
- Ability to move their elbow and wrist when supported against gravity
- Cortical stroke with hemiparesis, tactile sensation
- Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct
Exclusion Criteria:
- Bilateral paresis
- Diffuse/multiple lesion sites or multiple stroke events
- Hemispatial neglect or visual field cut that prevent visual feedback
- Shoulder pain and/or articular rigidity on the upper limb joint
- Severe sensory deficits indicated by the Two-Point Discrimination Test
- Botox injection to the affected upper extremity within the previous 4 months
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands
- Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
- Other neurological issues
Meet any of the contraindications to Delsys Trigno Sensors:
- Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators
- Irritated skin or open wounds
- Silver allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 - Assistance, Sham, Anti-Assistance
Group 1 receives all three interventions in the order of assistance, then sham (slack springs), then anti-assistance.
Each intervention corresponds to different settings on the device.
|
The device spring components will be tuned to produce an assistive supination torque on the forearm.
The device spring components will be tuned to slack springs to serve as a placebo.
The user will think they are receiving forces but in reality the device will not be providing any forces.
The device spring components will be tuned to produce a resistive supination torque on the forearm.
|
|
Experimental: Group 2 - Sham, Assistance, Anti-Assistance
Group 2 receives all three interventions in the order of sham (slack springs), then assistance, then anti-assistance.
Each intervention corresponds to different settings on the device.
|
The device spring components will be tuned to produce an assistive supination torque on the forearm.
The device spring components will be tuned to slack springs to serve as a placebo.
The user will think they are receiving forces but in reality the device will not be providing any forces.
The device spring components will be tuned to produce a resistive supination torque on the forearm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test (ARAT)
Time Frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
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Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
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Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper extremity portion of the Fugl-Meyer (FMUE)
Time Frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
|
Observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system
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Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
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Box and Blocks
Time Frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
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Measures change in unilateral gross motor dexterity
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Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electromyography using Delsys
Time Frame: Treatment phases (week 1, week 2 and week 3)
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Delsys sensors will be used to measure change in biceps activity
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Treatment phases (week 1, week 2 and week 3)
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Joint Kinematics using Microsoft Kinect
Time Frame: Treatment phases (week 1, week 2 and week 3)
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Markerless joint tracking system will be used to collect changes in the joint kinematics to identify changes in limb movement compensatory strategies
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Treatment phases (week 1, week 2 and week 3)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5.
- Lannin NA, Cusick A, Hills C, Kinnear B, Vogel K, Matthews K, Bowring G. Upper limb motor training using a Saebo orthosis is feasible for increasing task-specific practice in hospital after stroke. Aust Occup Ther J. 2016 Dec;63(6):364-372. doi: 10.1111/1440-1630.12330. Epub 2016 Sep 19.
- Ryali, P., Carella, T., McDermed, D., Perizes, V., Huang, F., & Patton, J. (2020). A Theoretical Framework for a Network of Elastic Elements Generating Arbitrary Torque Fields. In 2020 8th IEEE RAS/EMBS International Conference for Biomedical Robotics and Biomechatronics (BioRob) (pp. 286-291). IEEE.
- J. S. Sulzer, M. A. Peshkin and J. L. Patton, "MARIONET: An exotendon-driven rotary series elastic actuator for exerting joint torque," 9th International Conference on Rehabilitation Robotics, 2005. ICORR 2005., Chicago, IL, USA, 2005, pp. 103-108, doi: 10.1109/ICORR.2005.1501062.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- STU00218538
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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