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

June 5, 2026 updated by: Virginia Commonwealth University

Comparing the Attentional Demands and Functional Outcomes of Pattern Recognition and Direct Myoelectric Control in People With Transradial Amputation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Hanger Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shane R. Wurdeman, PhD
    • Virginia
      • Richmond, Virginia, United States, 232398
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Benjamin Darter, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pattern recognition controller (PRC) arm method intervention first and then the DC intervention
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.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refined Clothespin Relocation Test (rCRT)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Activity Measure for Upper Limb Amputees (BAM-ULA)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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.
Collected at Baseline, 3-Month, and 6-Month Assessments
Jebsen-Taylor Hand Function Test (JTHF)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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
Prosthetic Arm Control Survey (PACS)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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
Prosthesis Task Load Index (PROS-TLX)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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
PROMIS® Upper Extremity Function - 9-item
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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)
Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

United States Department of Defense
Hanger Institute for Clinical Research and Education, LLC

Investigators

  • Principal Investigator: Benjamin Darter, Virginia Commonwealth University
  • Principal Investigator: Shane R. Wurdeman, PhD, Hanger Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM20029330
  • HICRE-114 (Other Grant/Funding Number: US Department of Defense (DOD), Grant Office)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The deidentified data used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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