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The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Assistance, Sham, Anti-Assistance | Experimental | 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. |
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| Group 2 - Sham, Assistance, Anti-Assistance | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device tuned to Assistance | Device | The device spring components will be tuned to produce an assistive supination torque on the forearm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system | Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) |
| Measure | Description | Time Frame |
|---|---|---|
| Upper extremity portion of the Fugl-Meyer (FMUE) | Observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system | Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) |
| Box and Blocks |
| Measure | Description | Time Frame |
|---|---|---|
| Electromyography using Delsys | Delsys sensors will be used to measure change in biceps activity | Treatment phases (week 1, week 2 and week 3) |
| Joint Kinematics using Microsoft Kinect | Markerless joint tracking system will be used to collect changes in the joint kinematics to identify changes in limb movement compensatory strategies |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentino I Wilson | Contact | 630-398-2355 | viwilso2@uic.edu | |
| Courtney Celian, MSOT | Contact | 312-238-1560 | ccelian@sralab.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27646624 | Background | 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. | |
| 21261965 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device tuned to Sham (Slack Springs) | Device | 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. |
|
| Device tuned to Anti-Assistance | Device | The device spring components will be tuned to produce a resistive supination torque on the forearm. |
|
Measures change in unilateral gross motor dexterity |
| Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) |
| Treatment phases (week 1, week 2 and week 3) |
| 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. |
| Background | 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. |
| Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |