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

NCT07075042 | Recruiting FDA Device

• 2 other identifiers: HM20029330HICRE-114
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Refined Clothespin Relocation Test (rCRT)

  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 Outcomes (8)

• Brief Activity Measure for Upper Limb Amputees (BAM-ULA)

  Collected at Baseline, 3-Month, and 6-Month Assessments

• Jebsen-Taylor Hand Function Test (JTHF)

  Collected at Baseline, 3-Month, and 6-Month Assessments

• Orthotic and Prosthetic Users Survey (UEFS-P)

  Collected at Baseline, 3-Month, and 6-Month Assessments

• Patient Experience Measure (PEM)

  Collected at Baseline, 3-Month, and 6-Month Assessments

• Prosthesis Task Load Index (PROS-TLX)

  Collected at Baseline, 3-Month, and 6-Month Assessments

Study Arms (2)

Pattern recognition controller (PRC) arm method intervention first and then the DC intervention

ACTIVE COMPARATOR

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; Device: Training with DC; Device: PRC Device use in community and home; Device: DC Device use in community and home

DC intervention first and then the Pattern recognition controller (PRC) arm method intervention

ACTIVE COMPARATOR

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; Device: Training with DC; Device: PRC Device use in community and home; Device: DC Device use in community and home

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).

DC intervention first and then the Pattern recognition controller (PRC) arm method intervention; Pattern recognition controller (PRC) arm method intervention first and then the DC intervention

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).

DC intervention first and then the Pattern recognition controller (PRC) arm method intervention; Pattern recognition controller (PRC) arm method intervention first and then the DC intervention

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 intervention first and then the Pattern recognition controller (PRC) arm method intervention; Pattern recognition controller (PRC) arm method intervention first and then the DC intervention

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.

DC intervention first and then the Pattern recognition controller (PRC) arm method intervention; Pattern recognition controller (PRC) arm method intervention first and then the DC intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Any health condition that would prevent safely completing trial activities
• Discontinued use of a myoelectric prosthesis due to non-financial reasons

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• United States Department of Defense: collaborator
• Hanger Institute for Clinical Research and Education, LLC: collaborator

Study Sites (2)

Hanger Inc.

Austin, Texas, 78758, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 232398, United States

RECRUITING

Related Publications (26)

• Deeny S, Chicoine C, Hargrove L, Parrish T, Jayaraman A. A simple ERP method for quantitative analysis of cognitive workload in myoelectric prosthesis control and human-machine interaction. PLoS One. 2014 Nov 17;9(11):e112091. doi: 10.1371/journal.pone.0112091. eCollection 2014.

  PMID: 25402345 BACKGROUND

• Parr JVV, Galpin A, Uiga L, Marshall B, Wright DJ, Franklin ZC, Wood G. A tool for measuring mental workload during prosthesis use: The Prosthesis Task Load Index (PROS-TLX). PLoS One. 2023 May 4;18(5):e0285382. doi: 10.1371/journal.pone.0285382. eCollection 2023.

  PMID: 37141379 BACKGROUND

• Resnik LJ, Borgia ML, Clark MA, Graczyk E, Segil J, Ni P. Structural validity and reliability of the patient experience measure: A new approach to assessing psychosocial experience of upper limb prosthesis users. PLoS One. 2021 Dec 28;16(12):e0261865. doi: 10.1371/journal.pone.0261865. eCollection 2021.

  PMID: 34962943 BACKGROUND

• Resnik L, Borgia M, Heinemann AW, Stevens P, Clark MA, Ni P. The Upper Extremity Functional Scale for Prosthesis Users (UEFS-P): subscales for one and two-handed tasks. Disabil Rehabil. 2023 Nov;45(22):3768-3778. doi: 10.1080/09638288.2022.2138572. Epub 2022 Nov 10.

  PMID: 36357971 BACKGROUND

• Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.

  PMID: 14727700 BACKGROUND

• England DL, Miller TA, Stevens PM, Campbell JH, Wurdeman SR. Assessment of a Nine-Item Patient-Reported Outcomes Measurement Information System Upper Extremity Instrument Among Individuals With Upper Limb Amputation. Am J Phys Med Rehabil. 2021 Feb 1;100(2):130-137. doi: 10.1097/PHM.0000000000001531.

  PMID: 32675705 BACKGROUND

• Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.

  PMID: 5788487 BACKGROUND

• Resnik L, Adams L, Borgia M, Delikat J, Disla R, Ebner C, Walters LS. Development and evaluation of the activities measure for upper limb amputees. Arch Phys Med Rehabil. 2013 Mar;94(3):488-494.e4. doi: 10.1016/j.apmr.2012.10.004. Epub 2012 Oct 17.

  PMID: 23085376 BACKGROUND

• Salminger S, Vujaklija I, Sturma A, Hasenoehrl T, Roche AD, Mayer JA, Hruby LA, Aszmann OC. Functional Outcome Scores With Standard Myoelectric Prostheses in Below-Elbow Amputees. Am J Phys Med Rehabil. 2019 Feb;98(2):125-129. doi: 10.1097/PHM.0000000000001031.

  PMID: 30153123 BACKGROUND

• Resnik L, Huang HH, Winslow A, Crouch DL, Zhang F, Wolk N. Evaluation of EMG pattern recognition for upper limb prosthesis control: a case study in comparison with direct myoelectric control. J Neuroeng Rehabil. 2018 Mar 15;15(1):23. doi: 10.1186/s12984-018-0361-3.

  PMID: 29544501 BACKGROUND

• Kyberd P, Hussaini A, Maillet G. Characterisation of the Clothespin Relocation Test as a functional assessment tool. J Rehabil Assist Technol Eng. 2018 Jan 18;5:2055668317750810. doi: 10.1177/2055668317750810. eCollection 2018 Jan-Dec.

  PMID: 31191921 BACKGROUND

• Kuiken T, Miller L, Lipschutz R, Stubblefield K, Dumanian G. Prosthetic command signals following targeted hyper-reinnervation nerve transfer surgery. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:7652-5. doi: 10.1109/IEMBS.2005.1616284.

  PMID: 17282053 BACKGROUND

• Morgan SJ, Askew RL, Hafner BJ. Measurements of Best, Worst, and Average Socket Comfort Are More Reliable Than Current Socket Comfort in Established Lower Limb Prosthesis Users. Arch Phys Med Rehabil. 2022 Jun;103(6):1201-1204. doi: 10.1016/j.apmr.2021.10.008. Epub 2021 Nov 6.

  PMID: 34748757 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Hays RD, Spritzer KL, Schalet BD, Cella D. PROMIS(R)-29 v2.0 profile physical and mental health summary scores. Qual Life Res. 2018 Jul;27(7):1885-1891. doi: 10.1007/s11136-018-1842-3. Epub 2018 Mar 22.

  PMID: 29569016 BACKGROUND

• Hudgins B, Parker P, Scott RN. A new strategy for multifunction myoelectric control. IEEE Trans Biomed Eng. 1993 Jan;40(1):82-94. doi: 10.1109/10.204774.

  PMID: 8468080 BACKGROUND

• Englehart K, Hudgins B. A robust, real-time control scheme for multifunction myoelectric control. IEEE Trans Biomed Eng. 2003 Jul;50(7):848-54. doi: 10.1109/TBME.2003.813539.

  PMID: 12848352 BACKGROUND

• Biddiss EA, Chau TT. Upper limb prosthesis use and abandonment: a survey of the last 25 years. Prosthet Orthot Int. 2007 Sep;31(3):236-57. doi: 10.1080/03093640600994581.

  PMID: 17979010 BACKGROUND

• Raichle KA, Hanley MA, Molton I, Kadel NJ, Campbell K, Phelps E, Ehde D, Smith DG. Prosthesis use in persons with lower- and upper-limb amputation. J Rehabil Res Dev. 2008;45(7):961-72. doi: 10.1682/jrrd.2007.09.0151.

  PMID: 19165686 BACKGROUND

• Berke GM, Fergason J, Milani JR, Hattingh J, McDowell M, Nguyen V, Reiber GE. Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss. J Rehabil Res Dev. 2010;47(4):361-71. doi: 10.1682/jrrd.2009.12.0193.

  PMID: 20803404 BACKGROUND

• Ostlie K, Lesjo IM, Franklin RJ, Garfelt B, Skjeldal OH, Magnus P. Prosthesis rejection in acquired major upper-limb amputees: a population-based survey. Disabil Rehabil Assist Technol. 2012 Jul;7(4):294-303. doi: 10.3109/17483107.2011.635405. Epub 2011 Nov 23.

  PMID: 22112174 BACKGROUND

• Datta D, Selvarajah K, Davey N. Functional outcome of patients with proximal upper limb deficiency--acquired and congenital. Clin Rehabil. 2004 Mar;18(2):172-7. doi: 10.1191/0269215504cr716oa.

  PMID: 15053126 BACKGROUND

• Armstrong TW, Williamson MLC, Elliott TR, Jackson WT, Kearns NT, Ryan T. Psychological distress among persons with upper extremity limb loss. Br J Health Psychol. 2019 Nov;24(4):746-763. doi: 10.1111/bjhp.12360. Epub 2019 Apr 3.

  PMID: 30941874 BACKGROUND

• Resnik L, Borgia M, Heinemann AW, Clark MA. Prosthesis satisfaction in a national sample of Veterans with upper limb amputation. Prosthet Orthot Int. 2020 Apr;44(2):81-91. doi: 10.1177/0309364619895201. Epub 2020 Jan 21.

  PMID: 31960734 BACKGROUND

• Hussaini A, Kyberd P. Refined clothespin relocation test and assessment of motion. Prosthet Orthot Int. 2017 Jun;41(3):294-302. doi: 10.1177/0309364616660250. Epub 2016 Jul 29.

  PMID: 27473641 BACKGROUND

• Resnik L, Borgia M, Acluche F. Brief activity performance measure for upper limb amputees: BAM-ULA. Prosthet Orthot Int. 2018 Feb;42(1):75-83. doi: 10.1177/0309364616684196. Epub 2017 Jan 16.

  PMID: 28091278 BACKGROUND

Study Officials

• Benjamin Darter

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Shane R. Wurdeman, PhD

  Hanger Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shane R. Wurdeman, PhD

CONTACT

281-829-4746; swurdeman@hanger.com

Bretta L. Fylstra, PhD

CONTACT

512-994-6685; bfylstra@hanger.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a 6-month crossover trial to compare two clinically established myoelectric control strategies for upper-limb prostheses: pattern recognition control (PRC) and conventional direct control (DC). Adult participants with unilateral transradial limb loss who are current prosthesis users will serve as their own controls by using both control methods during the study period. The intervention condition is PRC, which utilizes EMG signals from multiple electrodes distributed across the residual limb and applies pattern-classification algorithms to determine intended movements. The control condition is DC, a two-site strategy that relies on relative EMG signal amplitude from an antagonistic muscle pair. All participants will be provided with a transradial prosthesis equipped with a wrist unit and multi-function hand. Functional performance under PRC and DC will be directly compared to evaluate relative advantages and limitations of each control approach.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 20, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)