Prosthetic Training for Amputation

Overseen By Jason Baer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Health condition, Myoelectric prosthesis discontinued

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with an upper limb amputation become more comfortable and satisfied with their prosthetic devices. It will test two different training methods, Training with DC and Training with PRC, for controlling a prosthetic arm to determine which method is easier and more intuitive, potentially improving overall well-being. Participants will first try one method and then switch to the other, with each method used for three months. Those who have lost a forearm, have used a myoelectric (muscle-powered) prosthesis for at least three months, and wear their prosthetic at least four days a week may be well-suited for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative training methods that could enhance the prosthetic experience.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on prosthetic use and does not mention medication requirements.

What prior data suggests that these prosthetic training methods are safe?

Research shows that both the PRC and DC methods for controlling prosthetics are safe for users. Studies on the PRC method indicate it enhances users' control over their prosthetic hand, leading to increased satisfaction and comfort. Users generally report a positive experience with minimal risk of harm.

The DC method is the standard way most myoelectric prosthetic arms are controlled. Research has found it effective and well-accepted by users, suggesting it is unlikely to cause unexpected problems.

Both methods aim to improve users' control over their prosthetic arm, which can lead to greater satisfaction and less physical discomfort. Overall, both methods appear to be safe choices for those considering trials involving these prosthetic controls. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to enhance the use of myoelectric prostheses for individuals with amputations. Unlike the standard two-site control method (DC), which is currently the norm, the PRC arm controller method offers a potentially more intuitive way to control prosthetic limbs. By comparing these two approaches, the trial aims to find out if the PRC method can improve the ease and effectiveness of prosthetic use, offering users better control and functionality. This could lead to significant improvements in the quality of life for people with amputations.

What evidence suggests that this trial's prosthetic training methods could be effective for improving prosthesis use?

This trial will compare the PRC arm controller method with the DC method for operating prosthetic devices. Research has shown that the PRC arm controller method may make prosthetic operation easier, leading to better performance and greater satisfaction. Many users report that this method is simpler than traditional systems, potentially resulting in more frequent use and an improved quality of life. While the DC, or standard method, remains a reliable choice, the PRC method might offer additional benefits in ease and comfort. Participants in this trial will experience both methods to assess their effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Benjamin Darter

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone transradial amputation and are experiencing challenges with their prosthetic devices. Ideal participants should be seeking to improve their device use and overall quality of life through training.

Inclusion Criteria

Previous or current use of a myoelectric device for 3 months or longer

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will undergo interventions with both PRC and DC arm controller methods, each with a transradial prosthesis

6 months

Regular visits for assessments and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DC Device use in community and home
• PRC Device use in community and home
• Training with DC
• Training with PRC

Trial Overview The study is examining how different types of prosthesis training affect attentional demands and everyday functioning. Participants will receive training with a PRC (prosthetic device) and DC (another type), then use these in daily life settings like home or community.

How Is the Trial Designed?

Group I: PRC arm controller method intervention first and then the DC intervention Active Control 4 Interventions

This arm will have the PRC arm controller method intervention first. The intervention condition in this study is PRC arm controller method. The control condition is DC, the standard-of-care, two-site controller strategy used in most myoelectric prostheses. Participants in the study will be provided a transradial prosthesis with a wrist unit and multi-function hand as part of this study.

Group II: the DC intervention first and then the PRC arm controller method intervention Active Control 4 Interventions

This arm will have the DC arm (standard of care) intervention first.The intervention condition in this study is PRC arm controller method. The control condition is DC, the standard-of-care, two-site controller strategy used in most myoelectric prostheses. Participants in the study will be provided a transradial prosthesis with a wrist unit and multi-function hand as part of this study.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07075042

Study Details | NCT07075042 | Comparing the Attentional ... The intervention condition in this study is PRC arm controller method. The control condition is DC, the standard-of-care, two-site controller ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10089583/

Bio-robotics research for non-invasive myoelectric neural ... This is a perspective review of the last ten years of translational research and development efforts in non-invasive neural interfaces and robotics.

3. withpower.com withpower.com/trial/phase-amputations-8-2025-2ec12

Prosthetic Training for Amputation · Info for Participants This trial is for individuals who have undergone transradial amputation and are experiencing challenges with their prosthetic devices. Ideal participants should ...

4. medprofvideos.mayoclinic.org medprofvideos.mayoclinic.org/videos/rehabilitation-following-amputation

Rehabilitation following amputation Advances in prosthetic rehabilitation include socket design, components, the terminal device. Terminal devices can be faster, waterproof, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04272489

Pattern Recognition Prosthetic Control (Adaptation) Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7881655/

User training for machine learning controlled upper limb ... In this explorative study we compare outcomes of serious game training with conventional training, and machine learning control with the users' own one DoF ...

7. withpower.com withpower.com/trial/phase-amputations-7-2024-812b4

Glide Control for Upper Extremity Amputation This trial is for individuals with upper extremity amputation. Participants will use two types of prosthetic arms: a standard Direct Control (DC) prosthesis ...

8. mdpi.com mdpi.com/1424-8220/23/6/3111

Measurement of Functional Use in Upper Extremity ... In this paper, we extend a novel method for identifying upper extremity functional and nonfunctional use to a new patient population: upper limb amputees.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449377/

A Review of Current State-of-the-Art Control Methods for ... In this paper, we present a review of existing control strategies for lower-limb powered prostheses, including the control objectives, sensing capabilities, ...

10. science.org science.org/doi/10.1126/scitranslmed.abq3665

Improved control of a prosthetic limb by surgically creating ... This proof-of-concept study indicates that motor neural commands can be increased by creating electro-neuromuscular constructs using distributed nerve ...