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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Point Designs
Lafayette, Colorado, United States
NOT_YET_RECRUITINGChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGProsthetic 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.
Time frame: 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.
Time frame: Baseline (pre-fitting), 60 days post-fitting
Weekly Diary Entries
Throughout the study, subjects and their parents will fill out weekly logs asking their experiences during the day, number of hours wearing the device, descriptions of the tasks performed, and open-response sections to clarify/detail any other events. The weekly logs will be in sealed envelopes and not opened until the completion of the study by the experimenters.
Time frame: Through study completion, an average of 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.