NCT06655636 · Shirley Ryan AbilityLab
Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
What this study is about
The purpose of this study is to evaluate the safety, feasibility, and effectiveness 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.
View original scientific description
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.
Interventions
DEVICE
Device tuned to Assistance
The device spring components will be tuned to produce an assistive supination torque on the forearm.
DEVICE
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
Device tuned to Anti-Assistance
The device spring components will be tuned to produce a resistive supination torque on the forearm.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2025 · Source of record for eligibility and locations