NCT04763278

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

Completed NA Results posted Last updated 27 September 2024

What this trial tests

NA trial testing Point Digit in Amputation; Traumatic, Hand in 7 participants. Completed in 30 March 2022.

Timeline

7 January 2021

Primary endpoint
30 March 2022

30 March 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	7
Start date	7 January 2021
Primary completion	30 March 2022
Estimated completion	30 March 2022
Sites	2 locations across United States

Drugs / interventions tested

• Point Digit

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 Digit(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 Digits 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 Digit(s) without using contralateral hand (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 Digits were mounted to the socket

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 Digit(s) (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 Digits were mounted to the socket. Then, each participant attempted the vali

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 Digit(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 Digit has been met: Point Digit 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 Digits were mounted to the socket. Then,

Group	Value	95% CI
Prosthesis	100

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

User releases Point Digit(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 Digit has been met: Point Digit 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 Digits were mounted to the socket. Then

Group	Value	95% CI
Prosthesis	100

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

User positions Point Digit(s) into each of the locking positions (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 Digits were mounted to the socket. Then, each participant attempted the vali

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 (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 fabricated and Point Digits were mounted to the

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 Digit(s) for 10 seconds (Pass/Fail). This validation method was used to confirm the following user need of the Point Digit has been met: Point Digit 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 Digits were mounted to the socket. Then, each participant attem

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 Digit has been met: Point Digit 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 Digits 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 Digit has been met: Point Digit 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 Digits 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 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.

Publications & conference data

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