Trial Outcomes & Findings for To Assess the Utility of the Point Digit in a Clinical Take-home Study (NCT NCT04755790)
NCT ID: NCT04755790
Last Updated: 2024-01-24
Results Overview
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
COMPLETED
NA
13 participants
Day 0: no prosthesis (pre-fitting)
2024-01-24
Participant Flow
Participant milestones
| Measure |
No Prosthesis, Then Prosthesis
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
No Prosthesis (Day 0)
STARTED
|
13
|
|
No Prosthesis (Day 0)
COMPLETED
|
13
|
|
No Prosthesis (Day 0)
NOT COMPLETED
|
0
|
|
Prosthesis (Day 0)
STARTED
|
13
|
|
Prosthesis (Day 0)
COMPLETED
|
13
|
|
Prosthesis (Day 0)
NOT COMPLETED
|
0
|
|
Prosthesis (Day 30)
STARTED
|
13
|
|
Prosthesis (Day 30)
COMPLETED
|
11
|
|
Prosthesis (Day 30)
NOT COMPLETED
|
2
|
|
Prosthesis (Day 60)
STARTED
|
11
|
|
Prosthesis (Day 60)
COMPLETED
|
11
|
|
Prosthesis (Day 60)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess the Utility of the Point Digit in a Clinical Take-home Study
Baseline characteristics by cohort
| Measure |
All Participants
n=13 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0: no prosthesis (pre-fitting)Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
|
74.6 scores on a scale
Standard Deviation 34.0
|
PRIMARY outcome
Timeframe: Day 0: no prosthesis (pre-fitting)The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH)
|
29.8 score on a scale
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: Day 0: no prosthesis (pre-fitting)The Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Southampton Hand Assessment Procedure (SHAP)
|
70.9 score on a scale
Standard Deviation 29.5
|
PRIMARY outcome
Timeframe: Day 0: no prosthesis (pre-fitting)Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
EuroQol-5 Dimension (EQ-5D-5L)
|
84.5 score on a scale
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Day 0: with prosthesis, immediately post-fittingCapacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
|
84.0 scores on a scale
Standard Deviation 13.1
|
PRIMARY outcome
Timeframe: Day 0: with prosthesis, immediately post-fittingThe Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH)
|
21.4 score on a scale
Standard Deviation 12.8
|
PRIMARY outcome
Timeframe: Day 0: with prosthesis, immediately post-fittingThe Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Southampton Hand Assessment Procedure (SHAP)
|
69.9 score on a scale
Standard Deviation 20.7
|
PRIMARY outcome
Timeframe: Day 0: with prosthesis, immediately post-fittingDescriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
EuroQol-5 Dimension (EQ-5D-5L)
|
88.5 score on a scale
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: ~Day 30: with prosthesis, 30 days post-fittingCapacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
|
86.8 scores on a scale
Standard Deviation 10.6
|
PRIMARY outcome
Timeframe: ~Day 30: with prosthesis, 30 days post-fittingThe Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH)
|
16.0 score on a scale
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: ~Day 30: with prosthesis, 30 days post-fittingThe Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Southampton Hand Assessment Procedure (SHAP)
|
74.9 score on a scale
Standard Deviation 23.3
|
PRIMARY outcome
Timeframe: ~Day 30: with prosthesis, 30 days post-fittingDescriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
EuroQol-5 Dimension (EQ-5D-5L)
|
89.2 score on a scale
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: ~Day 60: with prosthesis, 60 days post-fittingCapacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) provides a comprehensive, performance based measure for upper limb prosthetic use with any upper-limb functional prosthesis at any amputation level through assessment of commonplace activities that take place in various planes of movement. Scale Title: Overall Performance. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
|
91.0 scores on a scale
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: ~Day 60: with prosthesis, 60 days post-fittingThe Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scale Title: DASH Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates worse outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH)
|
15.5 score on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: ~Day 60: with prosthesis, 60 days post-fittingThe Southampton Hand Assessment Procedure (SHAP) is a clinically validated hand function test. Originally developed to assess the effectiveness of upper limb prostheses, the SHAP has now been applied to assessment of musculoskeletal and neurological conditions. Scale Title: Index of Function. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
Southampton Hand Assessment Procedure (SHAP)
|
75.3 score on a scale
Standard Deviation 21.2
|
PRIMARY outcome
Timeframe: ~Day 60: with prosthesis, 60 days post-fittingDescriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Title: EQ-5D-5L Score. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Outcome measures
| Measure |
No Prosthesis, Then Prosthesis
n=11 Participants
Baseline outcome measurements will be performed without a prosthesis
Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting
Point Digit: Patient is fit with Point Digit partial hand prosthetic system
|
|---|---|
|
EuroQol-5 Dimension (EQ-5D-5L)
|
90.1 score on a scale
Standard Deviation 8.7
|
Adverse Events
No Prosthesis, Then Prosthesis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place