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

Amputation; Traumatic, Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763278
• Other study ID #: 253922
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: January 2023
• Source: Point Designs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Hand

Intervention

Device:
• Point Digit
The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket

Locations

Country	Name	City	State
United States	University of Colorado Denver | Anschutz Medical Campus	Aurora	Colorado
United States	Point Designs	Lafayette	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Point Designs	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAL-1: System Comfort Validation Test	User wears Point Digit(s) for a full day (Pass/Fail)	Day 1 (8 hours)
Primary	VAL-2: Unilateral Function Validation Test	User flexes and extends the Point Digit(s) without using contralateral hand (Pass/Fail)	Day 1 (10 minutes)
Primary	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)
Primary	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)
Primary	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)
Primary	VAL-5: Position Function Validation Test	User positions Point Digit(s) into each of the locking positions (Pass/Fail)	Day 1 (10 minutes)
Primary	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)
Primary	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)
Primary	VAL-8: Fine Motor Function Validation Test	User picks up 1 coin from a smooth tabletop (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-9: Overall Function & Robustness Validation Test	User performs VAL-1 through VAL-8 (Pass/Fail)	Day 1 (8 hours)