To Validate Point Mini User Needs

Point Designs

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

Amputation; Traumatic, Hand Amputation, Congenital

Interventions

Point MiniDEVICE

The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States

Point Designs

Lafayette, Colorado, United States

Outcomes

Primary Outcomes

VAL-1

User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)

Time frame: Day 1 (8 hours)

VAL-2

User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)