Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation

Virginia Commonwealth University (VCU)

Status: Not yet enrolling

Conditions: Amputation

Treatments: Device: Training with DC; Device: Training with PRC; Device: DC Device use in community and home; Device: PRC Device use in community and home

Study type: Interventional

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

Identifiers

NCT07075042

HM20029330

Details and patient eligibility

About

Regular prosthesis use by an individual with upper limb loss can help improve general well-being. Individuals who do not use their prosthesis report more significant functional disability and lower health-related quality of life. A significant proportion of individuals with upper limb loss report high levels of disuse or discontinued use of their prosthesis because of physical pain or psychological distress, perceptions that the device provides no functional benefit, undesirable aesthetics, and issues with fit, comfort, weight, or design of their prosthetic device. Being able to exert intuitive control over a device would theoretically pose a lower cognitive burden to the user, concomitantly increasing functional performance. This effect could bolster device use and satisfaction.

Full description

Pattern recognition controller (PRC) systems for upper limb prostheses are a replacement to conventional direct controller (DC) systems. For decades, two-site DC has been the primary method for controlling upper limb myoelectric prosthetic devices. The DC method involves recording surface electromyography (EMG) at two 'control sites', ideally an antagonistic muscle pair in the residual limb. Alternatively, PRC is an emerging approach to myoelectric control that can potentially address the key limitations of DC. PRC uses pattern classifiers to discern intended motions based on EMG signals recorded from multiple sites on the residual limb. PRC combines EMG signals captured from multiple electromyography sensors on the residual limb to determine control intent and subsequently translate that intent to the wrist and hand/terminal device unit, while DC relies on signal level from two sensors, with the dominant signal being translated into a movement intention to control the prosthesis. The PRC technique avoids the need to isolate muscle activations and non-intuitive triggers. PRC offers a potentially more natural and intuitive way to operate along a greater range of motion, as well as perform a larger number of hand grasps when compared to DC - particularly during tasks that are complex and require rapid switching between actions of the wrist and/or terminal device. PRC also allows the user to recalibrate control at any time, better accommodating day-to-day variations in socket fit and positioning of the electrodes over the targeted muscle sites. While both systems have been commercially available for more than a decade or more, there is lack of comparative evidence to inform clinical decisions and guide policy. The current trial will investigate potential functional advantages and disadvantages of PRC compared to DC.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Unilateral transradial limb loss
• At least 6 months since loss
• Previous or current use of a myoelectric device for 3 months or longer
• Use of a prosthesis at least 4 days each week
• Ability to read, write, and understand English
• Willingness to use each control strategy as primary device for 3 months each (6 months commitment total)

Exclusion criteria

• Any health condition that would prevent safely completing trial activities
• Discontinued use of a myoelectric prosthesis due to non-financial reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

PRC arm controller method intervention first and then the DC intervention

Active Comparator group

Description:

This arm will have the PRC arm controller method intervention first. The intervention condition in this study is PRC arm controller method. The control condition is DC, the standard-of-care, two-site controller strategy used in most myoelectric prostheses. Participants in the study will be provided a transradial prosthesis with a wrist unit and multi-function hand as part of this study.

Treatment:

Device: PRC Device use in community and home

Device: DC Device use in community and home

Device: Training with PRC

Device: Training with DC

the DC intervention first and then the PRC arm controller method intervention

Active Comparator group

Description:

This arm will have the DC arm (standard of care) intervention first.The intervention condition in this study is PRC arm controller method. The control condition is DC, the standard-of-care, two-site controller strategy used in most myoelectric prostheses. Participants in the study will be provided a transradial prosthesis with a wrist unit and multi-function hand as part of this study.

Treatment:

Device: PRC Device use in community and home

Device: DC Device use in community and home

Device: Training with PRC

Device: Training with DC