Recruiting

Prosthesis Control

Sponsor:

Virginia Commonwealth University

Code:

NCT07075042

Conditions

Amputation

Prosthesis Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Training with PRC

Training with DC

PRC Device use in community and home

DC Device use in community and home

Study Details

Brief 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

Study ID

NCT07075042

Start date

Jul, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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).

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).

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.

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.

Primary outcome measure

  • Refined Clothespin Relocation Test (rCRT) [ Time Frame: Collected at Baseline, 3-Month, and 6-Month Assessments ]

Central Contacts and Locations

Central contacts

Shane R. Wurdeman, PhD

281-829-4746swurdeman@hanger.com

Bretta L. Fylstra, PhD

512-994-6685bfylstra@hanger.com

Locations

Hanger Inc.

Recruiting

Austin, Texas, United States, 78758

Contacts

Shane R. Wurdeman, PhD

281-829-4746swurdeman@hanger.com

Bretta L. Fystra, PhD

512-994-6685bfylstra@hanger.com

Principal Investigator:

Shane R. Wurdeman, PhD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 232398

Contacts

Tiffany Amos

804-828-4766tdclory@vcu.edu

Principal Investigator:

Benjamin Darter, PT, PhD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Transradial Amputation
  • Direct Myoelectric Control
  • Pattern Recognition Controller (PRC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-06-08.