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

Summary

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.

Conditions

• Amputation
• Prosthesis Use

Interventions

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Hanger Institute for Clinical Research and Education, LLC

  collaborator INDUSTRY

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• Benjamin Darter · Virginia Commonwealth University

• Shane R. Wurdeman, PhD · Hanger Inc.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-07-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations