Pattern Recognition Prosthetic Control (Simultaneous)

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; NIH

Identifiers

NCT04272593

5R44HD085306 (U.S. NIH Grant/Contract)

120180276

Details and patient eligibility

About

This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.

Enrollment: 8 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 Gen2 device).
• 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: None (Open label)

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8 participants in 2 patient groups

Simultaneous Control

Experimental group

Description:

Simultaneous pattern recognition style of control allows prosthetic users to actuate more than one hand/arm function on their device at the same time.

Treatment:

Device: EMG-Pattern Recognition Controller

Conventional Control

Active Comparator group

Description:

Conventional, seamless sequential pattern recognition style of control allows prosthetic users to actuate a single hand or arm functions on their device at a time.

Treatment:

Device: EMG-Pattern Recognition Controller