Actively Recruiting

Phase Not Applicable
Age: 5Years - 15Years
All Genders
NCT06501092

To Assess the Utility of the Point Mini in a Clinical Take-home Study

Led by Point Designs · Updated on 2025-06-24

14

Participants Needed

2

Research Sites

58 weeks

Total Duration

On this page

Sponsors

P

Point Designs

Lead Sponsor

C

Children's Healthcare of Atlanta

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.

CONDITIONS

Official Title

To Assess the Utility of the Point Mini in a Clinical Take-home Study

Who Can Participate

Age: 5Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
  • Intact thumb with full range of motion
  • Fluent in English
  • Age between 5 and 15 years
Not Eligible

You will not qualify if you...

  • Patients with a residual limb that is unhealed from the amputation surgery
  • Unhealed wounds
  • Significant cognitive deficits as determined upon clinical evaluation
  • Significant neurological deficits as determined upon clinical evaluation
  • Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
  • Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
  • Serious uncontrolled medical problems as judged by the project therapist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Point Designs

Lafayette, Colorado, United States, 80026

Not Yet Recruiting

2

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30143

Actively Recruiting

Loading map...

Research Team

R

Rebecca Connolly

CONTACT

L

Levin Sliker, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here