Point Powered System for Hand Amputation

Not yet recruiting at 2 trial locations

Overseen By Levin Sliker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Point Designs

Disqualifiers: Unhealed wounds, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prosthetic system called the Point Powered system for individuals with partial hand amputations. Researchers aim to compare the effectiveness of this new system with the prosthetics patients currently use. Participants will use both their existing prosthetic and the Point Powered system to assess hand functionality and prosthesis usage frequency. Ideal candidates for this trial have lost part of one hand, specifically the index and/or middle fingers, but retain a fully movable thumb. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for enhanced hand function and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Point Powered System is safe for hand amputees?

Research shows that the Point Powered system is generally easy for users to handle. One study compared a bionic hand, like the Point Powered system, with other prosthetic devices. Users found it easy to use, even in challenging situations. Although the study did not specifically examine side effects, the system is designed for comfort and effective daily use.

Since this trial lacks a specific phase, the Point Powered system may still be in early testing, indicating that safety information is still being collected. However, comparisons with standard prosthetics suggest some confidence in its safety. Similar studies have not reported serious side effects, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Point Powered System for hand amputation is unique because it offers a dynamic and potentially more responsive alternative to current prosthetic options. Unlike standard prosthetics, which can range from passive devices to body-powered and myoelectric prostheses, the Point Powered System is designed to adapt and function in a way that mimics natural hand movements more closely. Researchers are excited about this system because it has the potential to improve everyday functionality and quality of life for users by providing enhanced control and comfort compared to traditional prosthetic solutions.

What evidence suggests that the Point Powered system is effective for hand amputation?

Research has shown that the Point Powered system, which participants in this trial may receive, could be a promising option for people with partial hand amputations. Studies have found that multi-grip myoelectric prosthetics—like the Point Powered system—help people perform daily tasks better and reduce pain compared to single-grip options. Users might find it easier to hold different objects and feel less discomfort. Additionally, powered partial hand prostheses, such as the Point Powered system, offer more features than traditional ones. These early findings suggest that the Point Powered system could improve hand function and overall quality of life for users. ^{6 7 8 9 10}

Who Is on the Research Team?

Levin Sliker, PhD

Principal Investigator

Point Designs

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have lost part of their hand but still have a fully functional thumb. They must speak English and have lost at least the index or middle finger up to the base joint (MCP level). People with unhealed wounds, serious medical issues, cognitive or neurological deficits, physical impairments that affect study participation, an unhealed amputation site, or uncontrollable pain cannot join.

Inclusion Criteria

Fluent in English

I am 18 years old or older.

My thumb can move fully and normally.

Exclusion Criteria

Serious uncontrolled medical problems as judged by the project therapist

I have wounds that have not healed.

I have been diagnosed with significant cognitive deficits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment 1

Participants are evaluated on their existing prosthetic treatment over a period of three months

3 months

3 visits (in-person)

Treatment 2

Participants are evaluated on the Point Powered system at 3 different points in time: immediately post-fitting, ~30 days post-fitting, and ~60 days post-fitting

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Point Powered System

Trial Overview The Point Powered partial hand prosthetic system is being tested against standard prosthetics in adult partial hand amputees. Participants will use each treatment for three months and be evaluated on function, subjective assessments, how much they use both hands together, and how long they wear the prosthesis.

How Is the Trial Designed?

Group I: Point Powered Experimental Treatment 1 Intervention

Outcome measurements will be performed after the subject has been fit with the Point Powered at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Group II: Current/No Device Active Control 1 Intervention

Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device.

Who Is Running the Clinical Trial?

Point Designs

Lead Sponsor

Trials

7

Recruited

70+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Infinite Biomedical Technologies

Industry Sponsor

Trials

7

Recruited

160+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

Citations

1. withpower.com withpower.com/trial/phase-amputation-traumatic-hand-10-2025-3fab4

Point Powered System for Hand Amputation The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8862656/

EFFECT OF MULTI-GRIP MYOELECTRIC PROSTHETIC ... This study evaluates the effect of multi-grip hands on the performance of daily activities, pain-related disability and prosthesis use, compared to single-grip ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/12/NCT06821412/Prot_SAP_000.pdf

Wireless Prosthetic Control Effectiveness Study To monitor upper limb prosthesis usage, we will deploy the methods used in prior studies to monitor linear acceleration, rotation and orientation (with respect ...

4. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R44EB030895&arg_ProgOfficeCode=57

Award Information | HHS TAGGS The Point Powered: A Robust Actuated Prosthetic Finger for Partial Hand Amputation. Award Number: R44EB030895. ORGANIZATION: NATIONAL INSTITUTE Of ...

5. researchgate.net researchgate.net/publication/289300594_Experiences_and_Outcomes_With_Powered_Partial_Hand_Prostheses_A_Case_Series_of_Subjects_With_Multiple_Limb_Amputations

A Case Series of Subjects With Multiple Limb Amputations Powered partial hand prostheses are a relatively new option in the prosthetic treatment of persons with partial hand amputations.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5751817/

Case-study of a user-driven prosthetic arm design Case-study of a user-driven prosthetic arm design: bionic hand versus customized body-powered technology in a highly demanding work environment. Wolf Schweitzer ...

7. ctv.veeva.com ctv.veeva.com/study/to-evaluate-the-clinical-impact-of-the-point-powered-system

To Evaluate the Clinical Impact of the Point Powered System The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06452472

NCT06452472 | Observational Study of People with ... Inclusion Criteria: Patient aged over 18 years old; Patient with a unilateral acquired or congenital complete amputation; Patient using a standard myoelectric ...

9. nature.com nature.com/articles/s41598-025-15652-y

The socio-economic impact of robotic prosthetics This study evaluates the economic and social impact of a robotics research project culminating in the development of Hannes, an advanced ...

10. ovid.com ovid.com/journals/pmar/fulltext/10.1002/pmrj.12764~current-and-emerging-prostheses-for-partial-hand-amputation

Current and emerging prostheses for partial hand amputation Vincent Partial 3 Active Thumb from Vincent Systems is an externally powered partial hand prosthesis for patients with thumb amputation. There is active ...