StrokeNCT06655636
Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
A study testing Device tuned to Assistance and Device tuned to Anti-Assistance in people with Stroke and Cerebral Vascular Accident, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebral Vascular Accident
- What is being tested?
- Device tuned to Assistance and Device tuned to Anti-Assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60610
Courtney Celian, OTR/L, 312-238-1560, ccelian@sralab.org
James Patton, PhD
About this study
Official title: Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
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.
Read the 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.
- Conditions
- Stroke, Cerebral Vascular Accident
- Being tested
- Device tuned to Assistance, Device tuned to Sham (Slack Springs), Device tuned to Anti-Assistance
- Keywords
- Upper Extremity, Rehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device tuned to AssistanceDevice
The device spring components will be tuned to produce an assistive supination torque on the forearm.
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-AssistanceDevice
The device spring components will be tuned to produce a resistive supination torque on the forearm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Device tuned to Assistance; Device: Device tuned to Sham (Slack Springs); Device: Device tuned to Anti-Assistance |
| 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. Receives: Device: Device tuned to Assistance; Device: Device tuned to Sham (Slack Springs); Device: Device tuned to Anti-Assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
Measured: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Secondary outcomes (2)
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
Measured: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Box and Blocks
Measures change in unilateral gross motor dexterity
Measured: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start4 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Lanphier Patton, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655636
- Sponsor's protocol ID
- STU00218538
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27646624Gijbels 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.
PubMed 21261965J. 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination
- ClinicalTrials.gov ID
- NCT06655636
- Acronym / sponsor ID
- STU00218538
- Conditions
- Stroke, Cerebral Vascular Accident
- Keywords
- Upper Extremity, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Assistance, Sham, Anti-Assistance | Experimental | Device: Device tuned to Assistance, Device: Device tuned to Sham (Slack Springs), Device: Device tuned to Anti-AssistanceGroup 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. |
| Group 2 - Sham, Assistance, Anti-Assistance | Experimental | Device: Device tuned to Assistance, Device: Device tuned to Sham (Slack Springs), Device: Device tuned to Anti-AssistanceGroup 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device tuned to AssistanceThe device spring components will be tuned to produce an assistive supination torque on the forearm. | Device | Group 1 - Assistance, Sham, Anti-Assistance, Group 2 - Sham, Assistance, Anti-Assistance |
| Device tuned to Sham (Slack Springs)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 | Group 1 - Assistance, Sham, Anti-Assistance, Group 2 - Sham, Assistance, Anti-Assistance |
| Device tuned to Anti-AssistanceThe device spring components will be tuned to produce a resistive supination torque on the forearm. | Device | Group 1 - Assistance, Sham, Anti-Assistance, Group 2 - Sham, Assistance, Anti-Assistance |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
2 secondary outcomes
Upper extremity portion of the Fugl-Meyer (FMUE)
Time frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Box and Blocks
Time frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 27646624Lannin 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.
- Background: PubMed 21261965Gijbels 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.
- BackgroundJ. 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.
- BackgroundRyali, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device tuned to Assistance and Device tuned to Anti-Assistance in people with Stroke and Cerebral Vascular Accident, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentino I Wilson (630-398-2355, viwilso2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655636, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.