Point Mini: Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Study 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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* Unilateral or bilateral partial hand limb differences
* Fluent in English or Spanish
* Ability to follow simple directions
* Age between 3 and 17 years
Exclusion Criteria:
* 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
Primary outcome measure(s)
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2) — Baseline (pre-fitting), 60 days post-fitting 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.
PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE) — Baseline (pre-fitting), 60 days post-fitting 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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