Novel Prosthetic Hook for Amputation

Overseen By Harrison Bartlett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Little Room Innovations, LLC

Disqualifiers: Visual impairments, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 1

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthetic hook designed for individuals with arm amputations. The goal is to determine if this novel hook outperforms current leading prosthetic devices. Participants will try various hooks, including the new one, to compare their effectiveness. This trial suits those who use a prosthetic arm and can safely operate these devices. Individuals without visual, mental, neurological, or musculoskeletal disorders may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative prosthetic technology.

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.

What prior data suggests that this novel prosthetic hook is safe?

Research shows that the Novel Prosthetic Hook is designed to enhance the functionality of prosthetic arms. This device addresses common issues users face with current prosthetic hooks. Although specific safety data from past human trials for this device is unavailable, its design prioritizes improved function, indicating that safety is a key focus.

Prosthetic devices undergo thorough testing to ensure user safety. The new hook is being studied to compare its performance with existing devices, suggesting confidence in its safety. Users of similar prosthetic technologies often report improved grip and hand movement, indicating positive experiences without major safety concerns.

While specific safety data for this new device is not yet available, it is expected to be well-tolerated like other prosthetic devices. Prospective trial participants are encouraged to ask the study team about any safety information from early testing or feedback from users of similar devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Novel Prosthetic Hook for amputees because it offers a unique way to improve functionality compared to traditional prosthetic hooks. Unlike current options that typically rely on fixed return springs, this new prosthetic hook aims to provide better adaptability and control through its innovative design. This could mean improved precision and ease of use for wearers, potentially enhancing their quality of life by allowing more natural and versatile movements.

What evidence suggests that this novel prosthetic hook is effective for amputation?

Studies have shown that new prosthetic devices, like the Novel Prosthetic Hook tested in this trial, often lead to positive results for users. Research indicates that these advanced prosthetics address common problems with traditional devices, such as limited movement and user fatigue. For example, body-powered devices, which rely on the user's own movements, can have drawbacks that newer designs aim to solve. Early tests of similar new prosthetics suggest they might be easier to use and more satisfying. One study even reported significant improvements in ease of use. This suggests that the Novel Prosthetic Hook in this trial could potentially outperform current options. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 who have lost an upper limb and can safely operate a prosthetic device. Participants must be proficient in English but cannot join if they have musculoskeletal, neurological, or visual impairments, or mental disorders.

Inclusion Criteria

I am between 18 and 80 years old.

Able to demonstrate proper functioning and safety of the terminal device

Are proficient in English

Exclusion Criteria

Have history of musculoskeletal disorders

Have mental impairments

Have history of neurological disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants complete tests with different prosthetic hooks: Novel Prosthetic Hook, Control Hook with Light Spring, and Control Hook with Heavy Spring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel Prosthetic Hook

Trial Overview The study tests a new prosthetic hook designed to improve grasping capabilities against traditional hooks with heavy and light springs. The goal is to see if the novel device performs better than current commercial options for those with upper limb loss.

How Is the Trial Designed?

Group I: Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a light return spring, then the Control Hook with a heavy return spring.

Group II: Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring) Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a heavy return spring, then the Control Hook with a light return spring.

Group III: Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring) Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Novel Prosthetic Hook, and then the Control Hook with a heavy return spring,

Group IV: Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Control Hook with a heavy return spring, and then the Novel Prosthetic Hook.

Group V: Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring) Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the the Control Hook with a heavy return spring, then Novel Prosthetic Hook, and then the Control Hook with a light return spring.

Group VI: Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook Experimental Treatment 3 Interventions

In this arm, participants will first complete the tests with the Control Hook with a heavy return spring, then the Control Hook with a light return spring, and then the Novel Prosthetic Hook.

Who Is Running the Clinical Trial?

Little Room Innovations, LLC

Lead Sponsor

Trials

1

Recruited

6+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7047902/

The current state of bionic limbs from the surgeon's viewpoint Bionic limb replacement promises to be available as a fully implantable, bidirectional device for the upper limb, controlled via implanted electrodes.

2. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/research-data-demonstrate-positive-outcomes-associated-with-novel-prosthetic-hand/mac-20463006

Research data demonstrate positive outcomes associated ... Research data demonstrate positive outcomes associated with novel prosthetic hand. Despite multiple advances in technology since the debut of ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0205653

The SoftHand Pro: Functional evaluation of a novel, flexible ... Summarizing the training results, limb-intact and limb loss groups showed similar gains overall, although there appeared to be a tendency for ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003687024001212

A novel approach for predicting usability of upper limb ... A study that evaluated the usability of various prosthetic devices reported that 53% of passive hand users, 50% of body-powered hook users, and 39% of ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01125-8

Testing and evaluation of lower limb prosthesis prototypes in ... A total of 270 outcome measures were identified, kinetic/kinematic gait parameters were most often reported. The majority of outcome measures ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07254247

A Unique Body-Powered Terminal Device With Enhanced ... We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10602892/

Mechanical assessment of novel compliant ... - PubMed Central This paper proposes novel compliant mechanisms for constructing hand prostheses based on soft robotics. Two models of prosthetic hands are developed in this ...

8. npdevices.com npdevices.com/wp-content/uploads/2023/12/ASHT-Dig-Sup.pdf

High-Strength, Novel Prosthetic Intervention for Finger ... Naked Prosthetics' individualized devices restore active grip, pinch, and dexterity, are robust, and are the first successful prostheses distal to the MCP ...

9. mdpi.com mdpi.com/2673-1592/4/3/32

Reimagining Prosthetic Control: A Novel Body-Powered ... The human body can generate a wide variety of control signals that could potentially be used to operate a prosthetic hand. Most practical ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190009B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of the OPRATM. Implant System for ...