Point Mini for Hand Amputation

Recruiting at 1 trial location

Overseen By Rebecca Connolly

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: 4

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Point Mini, a new prosthetic system, compared to current options for children with partial hand loss, including the absence of a device. Over three months, participants will use their current prosthetic setup for one month, followed by the Point Mini for two months. Researchers will assess factors such as bilateral hand use, prosthesis wear frequency, and overall user experience. The trial seeks children aged 5 to 15 who have lost at least their index or middle finger but retain a fully functional thumb. As an unphased trial, this study provides a unique opportunity to advance innovative prosthetic solutions for children.

Do I have 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 the Point Mini system is safe for children with partial hand deficiencies?

Research is investigating whether the Point Mini system is safe and effective for children with partial hand loss. Currently, specific safety information is unavailable, so side effects and children's ability to handle the device remain unclear. The trial is in an early stage, focusing on human safety, which may involve unknown risks. Participants should stay informed and discuss any concerns with the researchers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard prosthetic options, which include passive or body-powered devices, the Point Mini offers an innovative approach for individuals with hand amputations. This experimental device is designed to be seamlessly integrated and personalized, potentially providing improved functionality and comfort. Researchers are particularly excited about the Point Mini because it allows for detailed outcome measurements at multiple time points, which could lead to a deeper understanding of its benefits and long-term impact compared to existing prosthetic solutions.

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

This trial will compare the Point Mini system with current prosthetic options for children with partial hand amputation. Studies have shown that the Point Mini system can greatly improve hand function, with about 48% of users reporting they were "very satisfied" with its ease and comfort. It helps users hold things better by enhancing grip stability. The lightweight design also allows children to use it comfortably throughout the day. While more research is needed, early signs suggest that the Point Mini system offers a promising improvement over current prosthetic options. ^{1 3 5 6 7}

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 children with partial hand deficiencies due to congenital or traumatic amputation. Participants will be compared using their current prosthetic treatment, if any, against the Point Mini system.

Inclusion Criteria

Fluent in English

I have lost part of my hand, including at least the index or middle finger.

My thumb is fully functional.

Exclusion Criteria

I have wounds that have not healed.

Significant cognitive deficits as determined upon clinical evaluation

Significant neurological 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

Baseline Assessment

Baseline outcome measurements performed with subject's existing partial hand prosthetic treatment

4 weeks

1 visit (in-person)

Treatment with Point Mini

Participants use the Point Mini system and are evaluated on several metrics

8 weeks

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 Mini

Trial Overview

The study tests the effectiveness of the Point Mini system over a two-month period versus one month with their usual prosthesis or assistive device. It's a crossover design where kids use both treatments at different times and are assessed on function and usage.

How Is the Trial Designed?

Group I: Point Mini Experimental Treatment 1 Intervention

Outcome measurements will be performed after the subject has been fit with a prosthesis 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+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Partial hand amputations are common, with an incidence of about 1 in 18,000 people in western countries, yet treatment options have not significantly advanced due to challenges like anatomical variability and the complexity of restoring motor and sensory functions.

Current solutions for partial hand amputations often depend on skilled technicians for fitting rather than modern engineering techniques, highlighting a need for innovative approaches to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of the Partial Hand Amputation: An Engineering Perspective. Imbinto, I., Peccia, C., Controzzi, M., et al.[2022]

Citations

1.

withpower.com

withpower.com/trial/phase-amputation-congenital-10-2024-ca6fa

Point Mini Device for Hand Amputation

This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks.

2.

withpower.com

withpower.com/trial/phase-amputation-congenital-10-2024-b28ea

Point Mini for Hand Amputation

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, ...

3.

mdpi.com

mdpi.com/2076-3417/14/16/7274

Report on Prosthetic Fitting, Mobility, and Overall ...

The dimensions and ease of use were rated as “very satisfied” by 48% of patients (N = 13) (±0.9; ±1.2). Less than one-third were moderately ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7364768/

Affordable passive 3D-printed prosthesis for persons with ...

This study showed that the prosthesis enhanced the patient's manual handling capabilities, mainly in the form of grasp stability. The prosthesis was light ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666769X23000106

From iron hooks to moving hands: The evolution of partial ...

This article provides a historical background of partial hand prostheses, describes the current prosthetic classes, and highlights key techniques that ease ...

6.

bereflected.org

bereflected.org/clinical-trials/listings/340398/to-assess-the-utility/

Evaluating the Point Mini device in a clinical study.

This study will check how well the Point Mini system works for kids with partial hand loss compared to what they currently use.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03329326

Comparison of Prosthetic Assessment Tools and Factors ...

Therefore, the aim of this study is to determine psychometric properties of the existing instruments (SHAP, DASH, SF-36 and ACMC) in a large international data ...