Pattern Recognition Prosthetic Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-07-18

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a randomized crossover home trial consisting of two 8-week periods with an intermittent 1-week washout period (17 weeks total). Participants will use either simultaneous control or convention seamless, sequential control in the first 8-week period followed by using the opposite control style in the second 8-week period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simultaneous Control

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

Group Type EXPERIMENTAL

EMG-Pattern Recognition Controller

Intervention Type DEVICE

Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.

Conventional Control

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.

Group Type ACTIVE_COMPARATOR

EMG-Pattern Recognition Controller

Intervention Type DEVICE

Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.

Interventions

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EMG-Pattern Recognition Controller

Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.

Intervention Type DEVICE

Other Intervention Names

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Coapt Complete Control Gen2

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No