To Assess the Utility of the Point Mini in a Clinical Take-home Study
2 other identifiers
interventional
14
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
June 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 26, 2026
June 1, 2026
2.1 years
July 5, 2024
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2)
The PUFI-2 is a measure of manual ability for children with upper limb impairment with and without a prosthesis. PUFI-2 consists of a questionnaire listing 23-27 manual activities and asks how the child performs the activity, how difficult it is to complete, and whether the prosthesis is useful or not. Both self-report and parent proxy-report versions are available.
Baseline (pre-fitting), 60 days post-fitting
PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE)
The PROMIS Ped - UE is a questionnaire that measures upper extremity physical function specifically in children. Both self-report and parent proxy-report versions are available.
Baseline (pre-fitting), 60 days post-fitting
Secondary Outcomes (1)
Weekly Diary Entries
Through study completion, an average of 3 months
Study Arms (2)
Current/No Device
NO INTERVENTIONBaseline 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.
Point Mini
EXPERIMENTALOutcome measurements will be performed \~60 days after the subject has been fit with a prosthesis, with additional visits occurring immediately post-fitting and \~30 days post-fitting.
Interventions
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Eligibility Criteria
You may qualify if:
- Unilateral or bilateral partial hand limb differences
- Fluent in English or Spanish
- Ability to follow simple directions
- Age between 3 and 17 years
You may not qualify if:
- Patients with any unhealed wounds on their residual limb(s)
- Significant cognitive deficits as determined upon clinical evaluation
- Inability to follow simple directions
- Significant physical deficits including pain and scarring impacting the design and fitting of the Point Mini prosthesis
- Other psychosocial, personal, and medical co-morbidities expressed by the subject, family or study personnel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Point Designs
Lafayette, Colorado, 80026, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30143, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Levin Sliker, PhD
Point Designs
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2024
First Posted
July 15, 2024
Study Start
June 18, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share