Amputation; Traumatic, Hand
Conditions
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.
Interventions
DEVICEPoint Partial
The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
Sponsors
University of Colorado, Denver
Point Designs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAL-1: System Comfort Validation Test | 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. |
| VAL-2: Unilateral Function Validation Test | 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 the socket. Then, each participant attempted the validation test. |
| VAL-3.1: System Robustness Validation Test With 25 lb Bag | 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 the validation test. |
| VAL-3.2: Robustness Validation Test With Hammer | 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. Then, each participant attempted the validation test. |
| VAL-4: Object Release Validation Test | 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 socket. Then, each participant attempted the validation test. |
| VAL-5: Position Function Validation Test | 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 the validation test. |
| VAL-6: Extension Function Validation Test | 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 fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test. |
| VAL-7: Grip Functions Validation Test | 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 participant attempted the validation test. |
| VAL-8: Fine Motor Function Validation Test | 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. |
| VAL-9: Overall Function & Robustness Validation Test | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prosthesis Patient is temporarily fit with Point Partial partial finger prosthetic system
Point Partial: The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Prosthesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
VAL-1: System Comfort Validation Test
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.
Time frame: Day 1 (8 hours)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-1: System Comfort Validation Test | 100 % of participants who Passed test |
Primary
VAL-2: Unilateral Function Validation Test
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 the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-2: Unilateral Function Validation Test | 100 % of participants who Passed test |
Primary
VAL-3.1: System Robustness Validation Test With 25 lb Bag
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 the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-3.1: System Robustness Validation Test With 25 lb Bag | 100 % of participants who Passed test |
Primary
VAL-3.2: Robustness Validation Test With Hammer
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. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-3.2: Robustness Validation Test With Hammer | 100 % of participants who Passed test |
Primary
VAL-4: Object Release Validation Test
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 socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-4: Object Release Validation Test | 100 % of participants who Passed test |
Primary
VAL-5: Position Function Validation Test
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 the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-5: Position Function Validation Test | 100 % of participants who Passed test |
Primary
VAL-6: Extension Function Validation Test
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 fabricated and Point Partials were mounted to the socket. Then, each participant attempted the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-6: Extension Function Validation Test | 100 % of participants who Passed test |
Primary
VAL-7: Grip Functions Validation Test
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 participant attempted the validation test.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-7: Grip Functions Validation Test | 100 % of participants who Passed test |
Primary
VAL-8: Fine Motor Function Validation Test
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.
Time frame: Day 1 (10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-8: Fine Motor Function Validation Test | 100 % of participants who Passed test |
Primary
VAL-9: Overall Function & Robustness Validation Test
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.
Time frame: Day 1 (8 hours)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prosthesis | VAL-9: Overall Function & Robustness Validation Test | 100 % of participants who Passed test |