Prosthesis Control Systems for Arm Amputation

Recruiting at 9 trial locations

Overseen By Christopher Hunt, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Infinite Biomedical Technologies

Disqualifiers: Unhealed limb, Cognitive deficits, Neurological deficits, Physical deficits, Uncontrolled pain, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Glide prosthesis control system simplifies the use of an artificial arm compared to the Pattern Recognition system. Researchers seek to identify which system reduces the workload for users and their care teams. Participants will test both systems in varying sequences to assess their effectiveness. The trial seeks individuals who have lost part of an arm and are new to these prosthesis systems. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance prosthesis technology for future users.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these prosthesis control systems are safe for arm amputation?

Research shows that myoelectric control systems, such as the Glide Control System, are generally safe for use. Extensive use of these systems indicates a strong safety record. Although specific safety data for Glide is unavailable, it operates by using sensors to detect muscle signals to control the prosthetic limb.

The Pattern Recognition System also employs this method. It has undergone improvements over time and is a common approach for controlling artificial arms. Many studies have examined the functionality of these systems, though they do not specifically address safety issues.

Both systems rely on well-studied technology, suggesting they are likely safe, despite the absence of specific safety data for either system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these prosthesis control systems for arm amputation because they offer innovative ways to improve how prosthetic arms function and feel. Unlike traditional prosthetics, which often rely on mechanical or body-powered systems, the Glide Control System and Pattern Recognition System use advanced technology to enhance control. The Glide Control System provides intuitive movement by allowing users to control the prosthetic with minimal effort, while the Pattern Recognition System captures electrical signals from the user's muscles to provide more natural, fluid movements. These systems have the potential to significantly improve the quality of life for individuals with arm amputations by offering more precise and responsive control over their prosthetic limbs.

What evidence suggests that this trial's prosthesis control systems could be effective for arm amputation?

This trial will compare two prosthesis control systems for arm amputation: the Glide Control System and the Pattern Recognition System. Research has shown that the Glide Control System can make using upper limb prostheses easier and more satisfying, helping people perform tasks better and reducing fatigue compared to other systems. The Pattern Recognition System, which uses muscle signals to control the prosthesis, has effectively improved users' ability to manage everyday activities. Both systems have shown promising results in enhancing prosthesis handling, but they operate differently. Glide simplifies control, while Pattern Recognition uses muscle patterns for more natural use. Each system offers advantages based on user needs and preferences. Participants in this trial will experience both systems, with one group using the Glide system first and the other group starting with the Pattern Recognition system. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single below-elbow or above-elbow amputation, who have healed limbs and are candidates for advanced myoelectric prostheses. It's not suitable for those with prior experience in the control systems being tested, skin issues affected by electrodes, serious cognitive or uncontrolled medical problems, unhealed limbs from surgery, significant neurological issues, physical deficits that limit participation, or uncontrollable pain.

Inclusion Criteria

Candidate for 2+ degree-of-freedom (DOF) myoelectric prosthesis as determined by the study prosthetist

I am 18 years old or older.

I have lost one arm above the wrist or elbow, and the area has healed.

Exclusion Criteria

Prior experience with Pattern Recognition or Glide control

Individuals with easily damaged or sensitive skin who would not tolerate EMG electrodes

Significant cognitive deficits as determined upon clinical evaluation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a Glide-controlled or Pattern Recognition-based upper limb prosthesis, with adjustments and monitoring

24 weeks

Weekly monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glide Control System
• Pattern Recognition System

Trial Overview The study compares two types of prosthesis control systems: Glide Control System and Pattern Recognition System. The aim is to see if Glide reduces the burden on patients and clinicians compared to Pattern Recognition when controlling a myoelectric prosthesis with multiple degrees of freedom.

How Is the Trial Designed?

Group I: Pattern Recognition then Glide Experimental Treatment 2 Interventions

Participants use a Pattern Recognition-based upper limb prosthesis first, followed by a Glide-controlled upper limb prosthesis.

Group II: Glide then Pattern Recognition Experimental Treatment 2 Interventions

Participants use a Glide-controlled upper limb prosthesis first, followed by a Pattern Recognition-based upper limb prosthesis.

Who Is Running the Clinical Trial?

Infinite Biomedical Technologies

Lead Sponsor

Trials

7

Recruited

160+

Medical Center Orthotics and Prosthetics

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222085

Long-Term Stability of the Glide Control Strategy This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06539936

Regulatory Clearance of the Glide Control Strategy for ... The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared ...

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

Glide Control for Upper Extremity Amputation The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6206495/

Evaluation of Performance-Based Outcome Measures for the ... Objective performance-based outcome measures (OMs) have the potential to provide unbiased and reproducible assessments of limb function.

5. mdpi.com mdpi.com/2673-1592/6/2/22

Upper Limb Prostheses by the Level of Amputation This review article aims to provide an updated and comprehensive overview of the latest trends in adult upper limb prostheses, specifically targeting various ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240884.pdf

April 15, 2024 Infinite Biomedical Technology LLC Prithul Bom ... Glide is a surface electromyography (EMG) electrode and control system intended to be used with an upper limb prosthesis. Glide detects ...

7. trialx.com trialx.com/clinical-trials/listings/305928/regulatory-clearance-of-the-glide-control-strategy-for-upper-limb-prostheses/

Regulatory Clearance of the Glide Control Strategy for ... The Glide system is capable of recording usage data during these at-home periods (regardless of which control system is active at a given time).