NCT04272489

Pattern Recognition Prosthetic Control

Efficacy of Control System Adaptation in Improving Upper-Extremity Prosthetic Limb Wear Time in a Real-World Setting, a Randomized Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Coapt, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.

Conditions

• Prosthesis User
• Congenital Amputation of Upper Limb
• Amputation; Traumatic, Limb

Interventions

Type	Name	Description
DEVICE	EMG-Pattern Recognition Controller	Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device in a home trial.

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2020-02-17
• Last updated: 2022-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study