AmputationNCT07075042
Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation
A study testing Training with PRC, Training with DC and PRC Device use in community and home in people with Amputation and Prosthesis Use, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Prosthesis Use
- What is being tested?
- Training with PRC, Training with DC and PRC Device use in community and home
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Any health condition that would prevent safely completing trial activities
- Discontinued use of a myoelectric prosthesis due to non-financial reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hanger Inc.
Austin, Texas, 78758
Shane R. Wurdeman, PhD, 281-829-4746, swurdeman@hanger.com
Bretta L. Fystra, PhD, 512-994-6685, bfylstra@hanger.com
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 232398
Tiffany Amos, 804-828-4766, tdclory@vcu.edu
Benjamin Darter, PT, PhD
About this study
Official title: Comparing the Attentional Demands and Functional Outcomes of Pattern Recognition and Direct Myoelectric Control in People With Transradial Amputation
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.
Read the 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.
- Conditions
- Amputation, Prosthesis Use
- Being tested
- Training with PRC, Training with DC, PRC Device use in community and home, DC Device use in community and home
- Keywords
- Transradial Amputation, Direct Myoelectric Control, Pattern Recognition Controller (PRC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with PRCDevice
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 DCDevice
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 homeDevice
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 homeDevice
After the training sessions, all subjects will use the DC device in their homes, just in a different order.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Training with PRC; Device: Training with DC; Device: PRC Device use in community and home; Device: DC Device use in community and home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Secondary outcomes (8)
Brief Activity Measure for Upper Limb Amputees (BAM-ULA)
The BAM-ULA measures an upper limb prosthesis user's ability to perform daily functional activities, including both unimanual and bimanual tasks. This outcome measure requires the participant to tuck their shirt into the back of their pants, place a 20-pound bag on a shelf, open a sealed water bottle and drink from it, remove a wallet from their back pocket, put wallet into their back pocket, take a gallon jug out of the refrigerator, open and pour with the jug, brush their hair, use a fork, and open a door with a doorknob. This outcome measure is scored based on task completion. A higher composite score is indicative of superior prosthesis control.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Jebsen-Taylor Hand Function Test (JTHF)
The JTHF is a standardized measure that tests an individual's unimanual hand function for completing activities of daily living. This test requires the participant to write, turn cards over, pick up and manipulate small objects, simulate feeding, stack checkers, and pick up lighter and heavier larger objects. Faster completion times are indicative of superior prosthesis control and hand function.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Orthotic and Prosthetic Users Survey (UEFS-P)
The UEFS-P measures functional status, quality of life, and satisfaction with devices and services among those receiving orthotic and prosthetic care. Participants will respond to 29 items. Higher scores reflect greater perceived function.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Patient Experience Measure (PEM)
The PEM measures social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness of upper limb prosthesis users. Higher scores reflect increased ability.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Prosthesis Task Load Index (PROS-TLX)
The PROS-TLX assesses the mental, physical, and emotional demands of using a prosthesis. The PROS-TLX is designed to rate the demand after a specified task is immediately finished. Participants will complete the measure after finishing the CRT. Lower ratings are indicative of lower mental, physical, or emotional demands.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Prosthetic Arm Control Survey (PACS)
A 7-item survey developed to assess differences in cognitive workload between PRC and DC of upper limb prostheses. The PACS is designed to rate workload after a specified task is just finished. Participants will complete the survey after finishing the CRT. Higher scores are indicative of less cognitive workload.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
PROMIS® Upper Extremity Function - 9-item
This standardized questionnaire is adapted from the validated PROMIS measurement system and consists of nine items focused on bilateral upper extremity function. The item set was carefully selected by upper-limb amputation clinicians to ensure clinical relevance.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Prosthetic Limb Users Survey of Upper Limb Attention (PLUS-Au)
A 25-item survey that measures attention to the prosthesis during a range of common activities. A higher score indicates increased attentional demands associated with prosthesis use in routine daily tasks.
Measured: Collected at Baseline, 3-Month, and 6-Month Assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start2 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Hanger Institute for Clinical Research and Education, LLC
- Responsible party
- Sponsor
- Investigators
- Benjamin Darter, Principal investigator, Virginia Commonwealth UniversityShane R. Wurdeman, PhD, Principal investigator, Hanger Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075042
- Sponsor's protocol ID
- HM20029330
- Other IDs
- HICRE-114
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The deidentified data used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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.
PubMed 25402345Parr 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.
PubMed 37141379Resnik 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.
PubMed 34962943Resnik 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.
PubMed 36357971Heinemann 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.
PubMed 14727700England 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.
PubMed 32675705Jebsen 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.
PubMed 5788487Resnik 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.
PubMed 23085376Salminger 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.
PubMed 30153123Resnik 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.
PubMed 29544501Kyberd 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.
PubMed 31191921Kuiken 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.
PubMed 17282053Morgan 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.
PubMed 34748757Cella 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.
PubMed 20685078Hays 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.
PubMed 29569016
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Attentional Demands and Functional Outcomes of Pattern Recognition and Direct Myoelectric Control in People With Transradial Amputation
- ClinicalTrials.gov ID
- NCT07075042
- Acronym / sponsor ID
- HM20029330
- Conditions
- Amputation, Prosthesis Use
- Keywords
- Transradial Amputation, Direct Myoelectric Control, Pattern Recognition Controller (PRC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Hanger Institute for Clinical Research and Education, LLC
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pattern recognition controller (PRC) arm method intervention first and then the DC intervention | Active comparator | Device: Training with PRC, Device: Training with DC, Device: PRC Device use in community and home, Device: DC Device use in community and homeParticipants 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. |
| DC intervention first and then the Pattern recognition controller (PRC) arm method intervention | Active comparator | Device: Training with PRC, Device: Training with DC, Device: PRC Device use in community and home, Device: DC Device use in community and homeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Any health condition that would prevent safely completing trial activities
- Discontinued use of a myoelectric prosthesis due to non-financial reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with PRCAll 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 | 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 DCAll 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 | 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 homeAfter the training sessions, all subjects will use the PRC device in their homes, just in a different order. | Device | 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 homeAfter the training sessions, all subjects will use the DC device in their homes, just in a different order. | Device | 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 |
Primary outcome
Refined Clothespin Relocation Test (rCRT)
Time frame: Collected at Baseline, 3-Month, and 6-Month Assessments
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 25402345Deeny 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.
- Background: PubMed 37141379Parr 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.
- Background: PubMed 34962943Resnik 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.
- Background: PubMed 36357971Resnik 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.
- Background: PubMed 14727700Heinemann 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.
- Background: PubMed 32675705England 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.
- Background: PubMed 5788487Jebsen 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.
- Background: PubMed 23085376Resnik 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.
- Background: PubMed 30153123Salminger 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.
- Background: PubMed 29544501Resnik 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.
- Background: PubMed 31191921Kyberd 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.
- Background: PubMed 17282053Kuiken 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.
- Individual participant dataSharing planned: Yes. The deidentified data used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Darter principal investigator
Virginia Commonwealth University
Shane R. Wurdeman, PhD principal investigator
Hanger Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with PRC, Training with DC and PRC Device use in community and home in people with Amputation and Prosthesis Use, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shane R. Wurdeman, PhD (281-829-4746, swurdeman@hanger.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refined Clothespin Relocation Test (rCRT) (time frame: Collected at Baseline, 3-Month, and 6-Month Assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075042, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.