StrokeNCT05180812
Safety and Feasibility of ExoNET
A study testing ExoNet Tuned to Gravity Support 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 preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Vascular Accident
- What is being tested?
- ExoNet Tuned to Gravity Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 12 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke (8 months post stroke)
- Available medical records and radiographic information about lesion locations
- Hemiparesis
- Some degree of both shoulder and elbow movement capability
- A "moderate" impairment (Fugl-Meyer score between 15-50)
Who cannot join
- Individuals under the age of 18
- Bilateral paresis
- Shoulder pain and/or articular rigidity on the upper limb joint
- Spasticity (Modified Ashworth Scale of 2)
- Botox injection to the affected upper extremity within the previous 4 months
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke
The purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient 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 using the ExoNET. Specifically, investigators want to see if the ExoNET tuned to gravity support will lead to a reduction in bicep muscle activity and an increase in range of motion. To accomplish this aim, we plan to have participants perform reaching, arm elevation and flexion task exercises wearing the ExoNET. To achieve these goals, we will use a wearable activity tracker (MiGo), to detect the number of activities performed, a wearable surface EMG system (Delsys) on the bicep muscles and a markerless system called the Kinect (version 2) to collect distribution of motion.
Investigators hypothesize that individuals with post-stroke arm movement deficits treated with ExoNET gravity compensation will improve their ARAT measures more than controls receiving a sham treatment. Secondarily, treated subjects will improve in other clinical metrics and will make more movements than controls.
- Conditions
- Stroke, Cerebral Vascular Accident
- Being tested
- ExoNet Tuned to Gravity Support
- 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.
ExoNet Tuned to Gravity SupportDevice
This study's primary goal is to test the safety, feasibility, and efficacy of the ExoNET device developed in the Robotics Lab at the Shirley Ryan AbilityLab. We want to observe if individuals using the ExoNET tuned to gravity support will notice a reduction in bicep muscle activity, leading to an improvement in functional outcome measures in stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Gravity Compensation | Experimental | The participants will be wearing the ExoNet device tuned to gravity support. Receives: Device: ExoNet Tuned to Gravity Support |
| Control Group: No Gravity Compensation | Sham comparator | The participants will be wearing the ExoNet device, but it will not be tuned to gravity support. Receives: Device: ExoNet Tuned to Gravity Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
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 4 (post evaluations), and week 9 (follow-up evaluations)
Secondary outcomes (3)
Fugl-Meyer
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 4 (post evaluations), and week 9 (follow-up evaluations)
Wolf Motor Function Test
Quantitative measure of change of upper extremity motor ability
Measured: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
Box and Blocks
Measures change in unilateral gross motor dexterity
Measured: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Mar 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
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
- NCT05180812
- Sponsor's protocol ID
- STU00216062
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celian C, Ryali P, Wilson V, Srivatsa A, Patton JL. A Wearable Anti-Gravity Supplement to Therapy Does Not Improve Arm Function in Chronic Stroke: A Randomized Pilot Trial. Neurorehabil Neural Repair. 2025 Sep;39(9):728-741. doi: 10.1177/15459683251338792. Epub 2025 Jun 19.
PubMed 40537460
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Upper Extremity ExoNET Support Post Stroke
- ClinicalTrials.gov ID
- NCT05180812
- Acronym / sponsor ID
- STU00216062
- Conditions
- Stroke, Cerebral Vascular Accident
- Keywords
- Upper Extremity, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2026 (estimated)
- First posted
- 6 Jan 2022 (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 preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient 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 using the ExoNET. Specifically, investigators want to see if the ExoNET tuned to gravity support will lead to a reduction in bicep muscle activity and an increase in range of motion. To accomplish this aim, we plan to have participants perform reaching, arm elevation and flexion task exercises wearing the ExoNET. To achieve these goals, we will use a wearable activity tracker (MiGo), to detect the number of activities performed, a wearable surface EMG system (Delsys) on the bicep muscles and a markerless system called the Kinect (version 2) to collect distribution of motion.
Investigators hypothesize that individuals with post-stroke arm movement deficits treated with ExoNET gravity compensation will improve their ARAT measures more than controls receiving a sham treatment. Secondarily, treated subjects will improve in other clinical metrics and will make more movements than controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Gravity Compensation | Experimental | Device: ExoNet Tuned to Gravity SupportThe participants will be wearing the ExoNet device tuned to gravity support. |
| Control Group: No Gravity Compensation | Sham comparator | Device: ExoNet Tuned to Gravity SupportThe participants will be wearing the ExoNet device, but it will not be tuned to gravity support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic or hemorrhagic stroke (8 months post stroke)
- Available medical records and radiographic information about lesion locations
- Hemiparesis
- Some degree of both shoulder and elbow movement capability
- A "moderate" impairment (Fugl-Meyer score between 15-50)
Key exclusion criteria (6 listed)
- Individuals under the age of 18
- Bilateral paresis
- Shoulder pain and/or articular rigidity on the upper limb joint
- Spasticity (Modified Ashworth Scale of 2)
- Botox injection to the affected upper extremity within the previous 4 months
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 |
|---|---|---|
| ExoNet Tuned to Gravity SupportThis study's primary goal is to test the safety, feasibility, and efficacy of the ExoNET device developed in the Robotics Lab at the Shirley Ryan AbilityLab. We want to observe if individuals using the ExoNET tuned to gravity support will notice a reduction in bicep muscle activity, leading to an improvement in functional outcome measures in stroke patients. | Device | Control Group: No Gravity Compensation, Experimental Group: Gravity Compensation |
Primary outcome
Action Research Arm Test
Time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system
3 secondary outcomes
Fugl-Meyer
Time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
Wolf Motor Function Test
Time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
Box and Blocks
Time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)
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 Apr 2025.
- Derived from this study: PubMed 40537460Celian C, Ryali P, Wilson V, Srivatsa A, Patton JL. A Wearable Anti-Gravity Supplement to Therapy Does Not Improve Arm Function in Chronic Stroke: A Randomized Pilot Trial. Neurorehabil Neural Repair. 2025 Sep;39(9):728-741. doi: 10.1177/15459683251338792. Epub 2025 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExoNet Tuned to Gravity Support 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (time frame: Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)). 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 NCT05180812, which also lists 1 linked publication.
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 Apr 2025.