NCT05012657

Validation of Point Partial User Needs With Partial Finger Amputees

Completed NA Results posted Last updated 8 November 2024

What this trial tests

NA trial testing Point Partial in Amputation; Traumatic, Hand in 5 participants. Completed in 31 December 2022.

Timeline

3 November 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Point Designs
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	5
Start date	3 November 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	2 locations across United States

Drugs / interventions tested

• Point Partial

Conditions studied

• Amputation; Traumatic, Hand — all drugs for Amputation; Traumatic, Hand →

Sponsor

Point Designs

Who can join

18 and older, any sex, with Amputation; Traumatic, Hand. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

VAL-1: System Comfort Validation Test Primary · Day 1 (8 hours)

User wears Point Partial(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.

Group	Value	95% CI
Prosthesis	100

VAL-2: Unilateral Function Validation Test Primary · Day 1 (10 minutes)

User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall allow the user to flex and extend finger without their second hand. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to th

Group	Value	95% CI
Prosthesis	100

VAL-3.1: System Robustness Validation Test With 25 lb Bag Primary · Day 1 (10 minutes)

User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted

Group	Value	95% CI
Prosthesis	100

VAL-3.2: Robustness Validation Test With Hammer Primary · Day 1 (10 minutes)

User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robust enough to operate in challenging environments. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket

Group	Value	95% CI
Prosthesis	100

VAL-4: Object Release Validation Test Primary · Day 1 (10 minutes)

User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be releasable while performing active grasps. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the sock

Group	Value	95% CI
Prosthesis	100

VAL-5: Position Function Validation Test Primary · Day 1 (10 minutes)

User positions Point Partial(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a smooth ratcheting mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted

Group	Value	95% CI
Prosthesis	100

VAL-6: Extension Function Validation Test Primary · Day 1 (10 minutes)

User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a reliable auto spring-back mechanism. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabr

Group	Value	95% CI
Prosthesis	100

VAL-7: Grip Functions Validation Test Primary · Day 1 (10 minutes)

User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have high grip surface friction. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participa

Group	Value	95% CI
Prosthesis	100

VAL-8: Fine Motor Function Validation Test Primary · Day 1 (10 minutes)

User picks up 1 coin from a smooth tabletop (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall have a pronounced fingernail. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.

Group	Value	95% CI
Prosthesis	100

VAL-9: Overall Function & Robustness Validation Test Primary · Day 1 (8 hours)

User performs VAL-1 through VAL-8 (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be robustly attached to mounting system. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.

Group	Value	95% CI
Prosthesis	100

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.