Validation of User Needs of the Point Digit With Partial Hand 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 Digit system. This study will be a single group intervention model where one group of 5 partial hand 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 User Needs of the Point Digit With Partial Hand Amputees

Conditions
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Amputation; Traumatic, Hand

Intervention / Treatment
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* Device: Point Digit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partial hand amputees with 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 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 occupational therapist 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 Digit partial hand prosthetic system | Device: Point Digit<br>* The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAL-1: System Comfort Validation Test | User wears Point Digit(s) for a full day (Pass/Fail) | Day 1 (8 hours) | 
| VAL-2: Unilateral Function Validation Test | User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-3.1: System Robustness Validation Test with 25 lb Bag | User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-3.2: Robustness Validation Test with Hammer | User grips a hammer with Point Digit(s) and drives a nail into a piece of wood (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-4: Object Release Validation Test | User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-5: Position Function Validation Test | User positions Point Digit(s) into each of the locking positions (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-6: Extension Function Validation Test | User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-7: Grip Functions Validation Test | User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-8: Fine Motor Function Validation Test | User picks up 1 coin from a smooth tabletop (Pass/Fail) | Day 1 (10 minutes) | 
| VAL-9: Overall Function & Robustness Validation Test | User performs VAL-1 through VAL-8 (Pass/Fail) | Day 1 (8 hours) |