To Assess the Utility of the Point Mini in a Clinical Take-home Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Point Mini.
- Who it may be relevant to
- Registry conditions: Amputation; Traumatic, Hand, Amputation, Congenital. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device Point Mini
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Primary outcome measures
- Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2) [Time frame: Baseline (pre-fitting), 60 days post-fitting]
- PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE) [Time frame: Baseline (pre-fitting), 60 days post-fitting]
Secondary outcome measures (1)
- Weekly Diary Entries [Time frame: Through study completion, an average of 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Point Designs — Lafayette
- Children's Healthcare of Atlanta — Atlanta
Identifiers
NCT: NCT06501092 · 445970 · 4R44HD113485-02