Cionic Neural Sleeve Multistim System: The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.
Study summary
This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.
Eligibility
Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Self-reported gait impairment
* Have access to a smartphone with iOS or Android operating system with Bluetooth capabilities and internet connection
* Ability to walk with or without an assistive device for up to 1 minute
* Leg measurements within sizing range of the Cionic Neural Sleeve
Exclusion Criteria:
* Daily occurrence of falls
* Implanted demand-type cardiac pacemaker or defibrillator
* Malignant tumor or existing thrombosis in the leg
* Fracture or dislocation in the leg that could be adversely affected by motion from stimulation
Primary outcome measure(s)
Number of Participants Able to Independently Exit a Stimulation Program Using the Cionic Neural Sleeve — Day 0, Week 6, Week 12 Participants' ability to independently exit (terminate) an active stimulation program on the Cionic Neural Sleeve will be assessed during study visits. Independence is defined as successful completion of the task without verbal cueing or physical assistance from study staff. Study staff will document whether the participant is able to exit the program independently (yes/no) at each visit.
Number of Participants Able to Independently Test Stimulation Using the Cionic Neural Sleeve — Day 0, Week 6, Week 12 Participants' ability to independently initiate and test stimulation on the Cionic Neural Sleeve will be assessed during study visits. Successful task completion is defined as the participant correctly activating stimulation and confirming perception of stimulation without assistance. Study staff will document successful independent testing (yes/no).
Number of Participants Able to Independently Calibrate the Cionic Neural Sleeve System — Day 0, Week 6, Week 12 Participants' ability to independently complete device calibration of the Cionic Neural Sleeve system will be assessed during study visits. Calibration is defined as completion of the device-guided calibration procedure without verbal or physical assistance. Study staff will document successful independent calibration (yes/no).
Safety of the Cionic Neural Sleeve — Day 0, Week 6, Week 12 To understand the device's safety profile and potential side effects, researchers will record any adverse events during their home use.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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