Pattern Recognition Prosthetic Control (Adaptation)

Coapt

Status: Completed

Conditions: Amputation; Traumatic, Limb; Congenital Amputation of Upper Limb; Prosthesis User

Treatments: Device: EMG-Pattern Recognition Controller

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04272489

W81XWH-17-1-0645 (Other Grant/Funding Number)

120190044

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects have an upper-limb difference (congenital or acquired) at the transradial (between the wrist and elbow), elbow disarticulation (at the elbow), transhumeral (between the elbow and shoulder), or shoulder disarticulation (at the shoulder) level.
• Subjects are suitable to be, or already are, a Coapt pattern recognition user (Coapt Complete Control Gen 2).
• Subjects are between the ages of 18 and 70.

Exclusion criteria

• Subjects with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback discussion.
• Subjects who are non-English speaking.
• Subjects who are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Adaptive Control

Experimental group

Description:

The adaptive control system updates the pattern recognition control algorithm by incorporating new EMG data each instance the prosthetic user recalibrates their device.

Treatment:

Device: EMG-Pattern Recognition Controller

Non-Adaptive Control

Active Comparator group

Description:

The conventional, non-adaptive control systems resets the pattern recognition control algorithm by deleting old EMG data each instance the prosthetic user recalibrate their device.

Treatment:

Device: EMG-Pattern Recognition Controller