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Validation of User Needs of the Point Digit With Partial Hand Amputees

Primary Purpose

Amputation; Traumatic, Hand

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point Digit
Sponsored by
Point Designs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputation; Traumatic, Hand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Denver | Anschutz Medical Campus
  • Point Designs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prosthesis

Arm Description

Patient is temporarily fit with Point Digit partial hand prosthetic system

Outcomes

Primary Outcome Measures

VAL-1: System Comfort Validation Test
User wears Point Digit(s) for a full day (Pass/Fail)
VAL-2: Unilateral Function Validation Test
User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail)
VAL-3.1: System Robustness Validation Test with 25 lb Bag
User lifts a 25 lb. bag with Point Digit(s) (Pass/Fail)
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)
VAL-4: Object Release Validation Test
User releases Point Digit(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)
VAL-5: Position Function Validation Test
User positions Point Digit(s) into each of the locking positions (Pass/Fail)
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)
VAL-7: Grip Functions Validation Test
User grips a 5 lb. cylindrical smooth object using Point Digit(s) for 10 seconds (Pass/Fail)
VAL-8: Fine Motor Function Validation Test
User picks up 1 coin from a smooth tabletop (Pass/Fail)
VAL-9: Overall Function & Robustness Validation Test
User performs VAL-1 through VAL-8 (Pass/Fail)

Secondary Outcome Measures

Full Information

First Posted
February 15, 2021
Last Updated
January 18, 2023
Sponsor
Point Designs
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04763278
Brief Title
Validation of User Needs of the Point Digit With Partial Hand Amputees
Official Title
Validation of User Needs of the Point Digit With Partial Hand Amputees
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Point Designs
Collaborators
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Hand

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Colorado Denver | Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Point Designs
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Validation of User Needs of the Point Digit With Partial Hand Amputees

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