Validation of Point Partial User Needs With Partial Finger Amputees

Study Overview
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Brief Summary
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The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees 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.

Official Title
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Validation of Point Partial User Needs With Partial Finger Amputees

Conditions
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Amputation; Traumatic, Hand

Intervention / Treatment
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* Device: Point Partial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partial finger amputees with partial absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met. Fluent in English Individuals aged 18 or greater Patients may present with either fused or mobile MCP joints. Exclusion Criteria: 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 OT evaluation Serious uncontrolled medical problems as judged by the project therapist.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prosthesis<br>Patient is temporarily fit with Point Partial partial finger prosthetic system | Device: Point Partial<br>* The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAL-1 | User wears Point Partial(s) for a full day (Pass/Fail) | Day 1 (8 hours) | 
| VAL-2 | User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-3.1 | User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-3.2 | User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-4 | User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-5 | User positions Point Partial(s) into each of the locking positions (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-6 | User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-7 | User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-8 | User picks up 1 coin from a smooth tabletop (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-9 | User performs VAL-1 through VAL-8 (Pass/Fail) | Day 1 (8 hours) |