Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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