NCT06655636

Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors

Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-10-23
• Last updated: 2025-01-09

Locations

1 site across 1 country: United States