Amputation, Congenital, Amputation; Traumatic, Hand
Conditions
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.
Interventions
DEVICEPoint Mini
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
Sponsors
Point Designs
Children's Healthcare of Atlanta
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Diary Entries | Through study completion, an average of 3 months | 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. |
Countries
United States
Contacts
CONTACTRebecca Connolly
CONTACTLevin Sliker, PhD
PRINCIPAL_INVESTIGATORLevin Sliker, PhD
Point Designs
Outcome results
None listed