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NCT Number: NCT07075042

Comparing the Attentional Demands and Functional Outcomes 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanger Inc., Austin, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bretta L. Fylstra, PhD

CONTACT

[email protected]

512-994-6685

Shane R. Wurdeman, PhD

CONTACT

[email protected]

281-829-4746

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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