Validation of Point Partial User Needs With Partial Finger Amputees
Primary Purpose
Amputation; Traumatic, Hand
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point Partial
Sponsored by
About this trial
This is an interventional device feasibility trial for Amputation; Traumatic, Hand
Eligibility Criteria
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.
Sites / Locations
- University of Colorado Denver | Anschutz Medical CampusRecruiting
- Point DesignsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prosthesis
Arm Description
Patient is temporarily fit with Point Partial partial finger prosthetic system
Outcomes
Primary Outcome Measures
VAL-1
User wears Point Partial(s) for a full day (Pass/Fail)
VAL-2
User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)
VAL-3.1
User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)
VAL-3.2
User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)
VAL-4
User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)
VAL-5
User positions Point Partial(s) into each of the locking positions (Pass/Fail)
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)
VAL-7
User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)
VAL-8
User picks up 1 coin from a smooth tabletop (Pass/Fail)
VAL-9
User performs VAL-1 through VAL-8 (Pass/Fail)
Secondary Outcome Measures
Full Information
NCT ID
NCT05012657
First Posted
August 12, 2021
Last Updated
September 26, 2022
Sponsor
Point Designs
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05012657
Brief Title
Validation of Point Partial User Needs With Partial Finger Amputees
Official Title
Validation of Point Partial User Needs With Partial Finger Amputees
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
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 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.
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
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prosthesis
Arm Type
Experimental
Arm Description
Patient is temporarily fit with Point Partial partial finger prosthetic system
Intervention Type
Device
Intervention Name(s)
Point Partial
Intervention Description
The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
Primary Outcome Measure Information:
Title
VAL-1
Description
User wears Point Partial(s) for a full day (Pass/Fail)
Time Frame
Day 1 (8 hours)
Title
VAL-2
Description
User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-3.1
Description
User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-3.2
Description
User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-4
Description
User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-5
Description
User positions Point Partial(s) into each of the locking positions (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-6
Description
User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-7
Description
User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-8
Description
User picks up 1 coin from a smooth tabletop (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-9
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Levin Sliker, PhD
Phone
7206004753
Email
levin@pointdesignsllc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Weir, PhD
Phone
8479121032
Email
richard.weir@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver | Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Weir, PhD
Phone
847-912-1032
Email
richard.weir@cuanschutz.edu
Facility Name
Point Designs
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levin Sliker, PhD
Phone
720-600-4753
Email
levin@pointdesignsllc.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of Point Partial User Needs With Partial Finger Amputees
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