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

NCT ID: NCT07075042

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief Summary

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.

Detailed 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.

Conditions

Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRC arm controller method intervention first and then the DC intervention

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.

Group Type: ACTIVE_COMPARATOR

Training with PRC

Intervention Type: DEVICE

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

Training with DC

Intervention Type: DEVICE

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

PRC Device use in community and home

Intervention Type: DEVICE

After the training sessions, all subjects will use the PRC device in their homes, just in a different order.

DC Device use in community and home

Intervention Type: DEVICE

After the training sessions, all subjects will use the DC device in their homes, just in a different order

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

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.

Group Type: ACTIVE_COMPARATOR

Training with PRC

Intervention Type: DEVICE

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

Training with DC

Intervention Type: DEVICE

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

PRC Device use in community and home

Intervention Type: DEVICE

After the training sessions, all subjects will use the PRC device in their homes, just in a different order.

DC Device use in community and home

Intervention Type: DEVICE

After the training sessions, all subjects will use the DC device in their homes, just in a different order

Interventions

Training with PRC

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

Intervention Type: DEVICE

Training with DC

All participants will receive in-person training with an onsite study prosthetist for the assigned controller strategy. The purpose of the training will be to instruct users on the care of the device formally and to achieve a basic level of functional performance. Training will be individualized according to clinical discretion consistent with clinical practice. Training will consist of up to four sessions to facilitate participants' use of the assigned controller system. The number of sessions will be competency-based (i.e., determined by the ability of each participant to explain or perform specified tasks). A standardized protocol and training checklist have been developed by clinical subject matter experts (i.e., upper limb prosthetists and occupational therapists).

Intervention Type: DEVICE

PRC Device use in community and home

After the training sessions, all subjects will use the PRC device in their homes, just in a different order.

Intervention Type: DEVICE

DC Device use in community and home

After the training sessions, all subjects will use the DC device in their homes, just in a different order

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Darter

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Central Contacts

Tiffany Amos

Role: CONTACT

tdclory@vcu.edu

804-828-4766

Jason Baer

Role: CONTACT

baerjl@vcu.edu

Facility Contacts

Tiffany Amos

Role: primary

tdclory@vcu.edu

804-828-4766

Other Identifiers

HM20029330

Identifier Type: -

Identifier Source: org_study_id