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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Virginia Commonwealth University • ClinicalTrials.gov ID: NCT07075042

Registry updated: 2026-09-08
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Description

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.

Interventions

  • 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.

Eligibility criteria

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

Conditions

Amputation Prosthesis Use

Locations

  • Hanger Inc. — Austin, Texas, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record