Amputation, Congenital, Amputation; Traumatic, Hand
Conditions
Brief summary
The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
Interventions
DEVICEPoint Mini
The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets
Sponsors
Point Designs
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Partial hand loss with at least index and/or middle fingers loss at the MCP level * Intact thumb with full range of motion * Fluent in English * Between the ages of 5 and 15 years
Exclusion criteria
* Patients with a residual limb that is unhealed from the amputation surgery * Unhealed wounds * Significant cognitive deficits as determined upon clinical evaluation * Significant neurological deficits as determined upon clinical evaluation * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation * Serious uncontrolled medical problems as judged by the project therapist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAL-1 | Day 1 (8 hours) | User wears Point Mini(s) for a entire session without discomfort (Pass/Fail) |
| VAL-2 | Day 1 (10 minutes) | User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail) |
| VAL-3.1 | Day 1 (10 minutes) | User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail) |
| VAL-3.2 | Day 1 (10 minutes) | User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail) |
| VAL-4 | Day 1 (10 minutes) | User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail) |
| VAL-5 | Day 1 (10 minutes) | User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail) |
| VAL-6 | Day 1 (10 minutes) | User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail) |
| VAL-7 | Day 1 (10 minutes) | User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail) |
| VAL-8 | Day 1 (10 minutes) | User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail) |
| VAL-9 | Day 1 (8 hours) | User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLevin Sliker, PhD
CEO, Point Designs
Outcome results
None listed