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| ID | Type | Description | Link |
|---|---|---|---|
| HICRE-114 | Other Grant/Funding Number | US Department of Defense (DOD), Grant Office |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Hanger Institute for Clinical Research and Education, LLC | INDUSTRY |
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Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.
Pattern recognition controller (PRC) systems for upper-limb prostheses are a clinically established alternative to conventional direct control (DC) systems. For decades, two-site DC has been the primary method for controlling myoelectric upper-limb prosthetic devices. DC relies on surface electromyography (EMG) recordings from two control sites, typically an antagonistic muscle pair in the residual limb, and uses relative signal amplitude to generate movement commands for the prosthesis.
PRC is a more recent, clinically established control strategy developed to address several limitations associated with DC. Rather than depending on isolated activation of two muscle sites, PRC captures EMG signals from multiple sensors across the residual limb and uses pattern-classification algorithms to identify the user's intended movement. By incorporating information from multiple EMG channels, PRC may provide more intuitive and natural control, support a broader range of wrist and terminal device motions, and reduce reliance on non-intuitive switching strategies-particularly during tasks requiring rapid transitions between movements. PRC systems also enable on-demand recalibration, allowing users to adjust control performance in response to day-to-day changes in socket fit or electrode positioning.
Although both PRC and DC systems are clinically established and have been used in practice, this study provides an opportunity to directly compare two clinically established control strategies. This trial will evaluate the functional advantages and disadvantages of PRC relative to DC when used by adults with unilateral transradial limb loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pattern recognition controller (PRC) arm method intervention first and then the DC intervention | Active Comparator | Participants randomized to this condition will first try the PRC controller for 3 months. Afterwards, participants will try the DC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions. |
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| DC intervention first and then the Pattern recognition controller (PRC) arm method intervention | Active Comparator | Participants randomized to this condition will first try the DC controller for 3 months. Afterwards, participants will try the PRC controller for 3 months. Participants in the study will be provided with a transradial prosthesis with either a choice of a wrist + electronic terminal device (ETD) OR a multi-articulating hand terminal device. The prosthesis will be fabricated to switch between the two control conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training with PRC | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Refined Clothespin Relocation Test (rCRT) | The rCRT measures upper limb prosthesis performance. The test requires participants to rotate each clothespin 90° before placing it onto the vertical bar, which necessitates use of more than one joint motion. Faster completion times are indicative of superior prosthesis control and dexterity. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Activity Measure for Upper Limb Amputees (BAM-ULA) | The BAM-ULA measures an upper limb prosthesis user's ability to perform daily functional activities, including both unimanual and bimanual tasks. This outcome measure requires the participant to tuck their shirt into the back of their pants, place a 20-pound bag on a shelf, open a sealed water bottle and drink from it, remove a wallet from their back pocket, put wallet into their back pocket, take a gallon jug out of the refrigerator, open and pour with the jug, brush their hair, use a fork, and open a door with a doorknob. This outcome measure is scored based on task completion. A higher composite score is indicative of superior prosthesis control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shane R. Wurdeman, PhD | Contact | 281-829-4746 | swurdeman@hanger.com | |
| Bretta L. Fylstra, PhD | Contact | 512-994-6685 | bfylstra@hanger.com |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Darter | Virginia Commonwealth University | Principal Investigator |
| Shane R. Wurdeman, PhD | Hanger Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanger Inc. | Recruiting | Austin | Texas | 78758 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25402345 | Background | Deeny S, Chicoine C, Hargrove L, Parrish T, Jayaraman A. A simple ERP method for quantitative analysis of cognitive workload in myoelectric prosthesis control and human-machine interaction. PLoS One. 2014 Nov 17;9(11):e112091. doi: 10.1371/journal.pone.0112091. eCollection 2014. | |
| 37141379 | Background | Parr JVV, Galpin A, Uiga L, Marshall B, Wright DJ, Franklin ZC, Wood G. A tool for measuring mental workload during prosthesis use: The Prosthesis Task Load Index (PROS-TLX). PLoS One. 2023 May 4;18(5):e0285382. doi: 10.1371/journal.pone.0285382. eCollection 2023. |
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The deidentified data used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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This study uses a 6-month crossover trial to compare two clinically established myoelectric control strategies for upper-limb prostheses: pattern recognition control (PRC) and conventional direct control (DC). Adult participants with unilateral transradial limb loss who are current prosthesis users will serve as their own controls by using both control methods during the study period. The intervention condition is PRC, which utilizes EMG signals from multiple electrodes distributed across the residual limb and applies pattern-classification algorithms to determine intended movements. The control condition is DC, a two-site strategy that relies on relative EMG signal amplitude from an antagonistic muscle pair. All participants will be provided with a transradial prosthesis equipped with a wrist unit and multi-function hand. Functional performance under PRC and DC will be directly compared to evaluate relative advantages and limitations of each control approach.
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| Training with DC | 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 | Device | After the training sessions, all subjects will use the PRC device in their homes, just in a different order. |
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| DC Device use in community and home | Device | After the training sessions, all subjects will use the DC device in their homes, just in a different order. |
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| Collected at Baseline, 3-Month, and 6-Month Assessments |
| Jebsen-Taylor Hand Function Test (JTHF) | The JTHF is a standardized measure that tests an individual's unimanual hand function for completing activities of daily living. This test requires the participant to write, turn cards over, pick up and manipulate small objects, simulate feeding, stack checkers, and pick up lighter and heavier larger objects. Faster completion times are indicative of superior prosthesis control and hand function. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Orthotic and Prosthetic Users Survey (UEFS-P) | The UEFS-P measures functional status, quality of life, and satisfaction with devices and services among those receiving orthotic and prosthetic care. Participants will respond to 29 items. Higher scores reflect greater perceived function. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Patient Experience Measure (PEM) | The PEM measures social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness of upper limb prosthesis users. Higher scores reflect increased ability. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Prosthesis Task Load Index (PROS-TLX) | The PROS-TLX assesses the mental, physical, and emotional demands of using a prosthesis. The PROS-TLX is designed to rate the demand after a specified task is immediately finished. Participants will complete the measure after finishing the CRT. Lower ratings are indicative of lower mental, physical, or emotional demands. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Prosthetic Arm Control Survey (PACS) | A 7-item survey developed to assess differences in cognitive workload between PRC and DC of upper limb prostheses. The PACS is designed to rate workload after a specified task is just finished. Participants will complete the survey after finishing the CRT. Higher scores are indicative of less cognitive workload. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| PROMIS® Upper Extremity Function - 9-item | This standardized questionnaire is adapted from the validated PROMIS measurement system and consists of nine items focused on bilateral upper extremity function. The item set was carefully selected by upper-limb amputation clinicians to ensure clinical relevance. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Prosthetic Limb Users Survey of Upper Limb Attention (PLUS-Au) | A 25-item survey that measures attention to the prosthesis during a range of common activities. A higher score indicates increased attentional demands associated with prosthesis use in routine daily tasks. | Collected at Baseline, 3-Month, and 6-Month Assessments |
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 232398 | United States |
|
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