RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-30
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06501092

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.

Ages Eligible for Study:5 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
  2. * Intact thumb with full range of motion
  3. * Fluent in English
  4. * Age between 5 and 15 years
  1. * Patients with a residual limb that is unhealed from the amputation surgery
  2. * Unhealed wounds
  3. * Significant cognitive deficits as determined upon clinical evaluation
  4. * Significant neurological deficits as determined upon clinical evaluation
  5. * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
  6. * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
  7. * Serious uncontrolled medical problems as judged by the project therapist

Contacts and Locations

Study Contact

Rebecca Connolly
CONTACT
720-600-4753
becca@pointdesigns.com
Levin Sliker, PhD
CONTACT
720-600-4753
levin@pointdesigns.com

Principal Investigator

Levin Sliker, PhD
PRINCIPAL_INVESTIGATOR
Point Designs

Study Locations (Sites)

Point Designs
Lafayette, Colorado, 80026
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30143
United States

Collaborators and Investigators

Sponsor: Point Designs

  • Levin Sliker, PhD, PRINCIPAL_INVESTIGATOR, Point Designs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Amputation; Traumatic, Hand
  • Amputation, Congenital