Trial Outcomes & Findings for Validation of User Needs of the Point Digit With Partial Hand Amputees (NCT NCT04763278)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Day 1 (8 hours)

Results posted on

2024-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Prosthesis Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-1: System Comfort Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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. Then, each participant attempted the validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-2: Unilateral Function Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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 validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-3.1: System Robustness Validation Test With 25 lb Bag	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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, each participant attempted the validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-3.2: Robustness Validation Test With Hammer	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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, each participant attempted the validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-4: Object Release Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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 validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-5: Position Function Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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 socket. Then, each participant attempted the validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-6: Extension Function Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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 attempted the validation test.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-7: Grip Functions Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-8: Fine Motor Function Validation Test	100 % of participants who Passed test

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthesis n=7 Participants Patient is temporarily fit with Point Digit partial hand prosthetic system Point Digit: The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
VAL-9: Overall Function & Robustness Validation Test	100 % of participants who Passed test

Adverse Events

Prosthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

Point Designs

Phone: 7206004753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place