RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Amputation; Traumatic, Hand
Intervention / Treatment

-

Contacts and Locations

Lafayette

Point Designs, Lafayette, Colorado, United States, 80026

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

5 Years to 15 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Point Designs,

Levin Sliker, PhD, PRINCIPAL_INVESTIGATOR, Point Designs

Study Record Dates

2026-08-31