Dysautonomia International

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

Purpose

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.

Conditions

Amputation
Prosthesis Use

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 6-month crossover trial with current upper limb prosthesis users. 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 with a transradial prosthesis featuring a wrist unit and a multi-function hand as part of this study.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Pattern recognition controller (PRC) arm method intervention first and then the DC intervention	This arm will have the pattern recognition controller (PRC) first. This is the intervention condition. 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.	Device: 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). 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). 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. 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
Active Comparator DC intervention first and then the Pattern recognition controller (PRC) arm method intervention	This arm will have the DC arm (standard of care) intervention first.The intervention condition in this study is pattern recognition controller (PRC) arm 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.	Device: 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). 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). 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. 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

Recruiting Locations

Virginia Commonwealth University
Richmond, Virginia 232398

Contact:
Tiffany Amos
804-828-4766
tdclory@vcu.edu

More Details

Status: Recruiting
Sponsor: Virginia Commonwealth University

Study Contact

Tiffany Amos
804-828-4766
tdclory@vcu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.