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

Official title

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

Overview

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.

Detailed description

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.

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
• 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
• 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.

Primary outcome measures

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

Secondary outcome measures (8)

• Brief Activity Measure for Upper Limb Amputees (BAM-ULA) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Jebsen-Taylor Hand Function Test (JTHF) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Orthotic and Prosthetic Users Survey (UEFS-P) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Patient Experience Measure (PEM) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Prosthesis Task Load Index (PROS-TLX) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Prosthetic Arm Control Survey (PACS) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• PROMIS® Upper Extremity Function - 9-item [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]
• Prosthetic Limb Users Survey of Upper Limb Attention (PLUS-Au) [Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Hanger Inc. — Austin
• Virginia Commonwealth University — Richmond

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07075042 · HM20029330 · HICRE-114

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗