Amputation; Traumatic, Hand
Conditions
Brief summary
This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
Interventions
DEVICEPoint Digit
Patient is fit with Point Digit partial hand prosthetic system
Sponsors
University of Colorado, Denver
Arm Dynamics
Point Designs
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Partial hand amputees with 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
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 occupational therapist evaluation * Serious uncontrolled medical problems as judged by the project therapist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 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. |
| Disability of the Arm, Shoulder and Hand (DASH) | 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. |
| Southampton Hand Assessment Procedure (SHAP) | 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. |
| EuroQol-5 Dimension (EQ-5D-5L) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 8 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
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.
Time frame: Day 0: no prosthesis (pre-fitting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 74.6 scores on a scale | Standard Deviation 34 |
Primary
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
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.
Time frame: Day 0: with prosthesis, immediately post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 84.0 scores on a scale | Standard Deviation 13.1 |
Primary
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
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.
Time frame: ~Day 30: with prosthesis, 30 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 86.8 scores on a scale | Standard Deviation 10.6 |
Primary
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
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.
Time frame: ~Day 60: with prosthesis, 60 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) | 91.0 scores on a scale | Standard Deviation 8.1 |
Primary
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: Day 0: no prosthesis (pre-fitting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Disability of the Arm, Shoulder and Hand (DASH) | 29.8 score on a scale | Standard Deviation 14.6 |
Primary
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: ~Day 30: with prosthesis, 30 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Disability of the Arm, Shoulder and Hand (DASH) | 16.0 score on a scale | Standard Deviation 9.9 |
Primary
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: ~Day 60: with prosthesis, 60 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Disability of the Arm, Shoulder and Hand (DASH) | 15.5 score on a scale | Standard Deviation 10.5 |
Primary
Disability of the Arm, Shoulder and Hand (DASH)
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.
Time frame: Day 0: with prosthesis, immediately post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Disability of the Arm, Shoulder and Hand (DASH) | 21.4 score on a scale | Standard Deviation 12.8 |
Primary
EuroQol-5 Dimension (EQ-5D-5L)
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.
Time frame: Day 0: no prosthesis (pre-fitting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | EuroQol-5 Dimension (EQ-5D-5L) | 84.5 score on a scale | Standard Deviation 12.5 |
Primary
EuroQol-5 Dimension (EQ-5D-5L)
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.
Time frame: Day 0: with prosthesis, immediately post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | EuroQol-5 Dimension (EQ-5D-5L) | 88.5 score on a scale | Standard Deviation 9.8 |
Primary
EuroQol-5 Dimension (EQ-5D-5L)
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.
Time frame: ~Day 30: with prosthesis, 30 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | EuroQol-5 Dimension (EQ-5D-5L) | 89.2 score on a scale | Standard Deviation 8.5 |
Primary
EuroQol-5 Dimension (EQ-5D-5L)
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.
Time frame: ~Day 60: with prosthesis, 60 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | EuroQol-5 Dimension (EQ-5D-5L) | 90.1 score on a scale | Standard Deviation 8.7 |
Primary
Southampton Hand Assessment Procedure (SHAP)
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.
Time frame: Day 0: with prosthesis, immediately post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Southampton Hand Assessment Procedure (SHAP) | 69.9 score on a scale | Standard Deviation 20.7 |
Primary
Southampton Hand Assessment Procedure (SHAP)
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.
Time frame: ~Day 60: with prosthesis, 60 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Southampton Hand Assessment Procedure (SHAP) | 75.3 score on a scale | Standard Deviation 21.2 |
Primary
Southampton Hand Assessment Procedure (SHAP)
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.
Time frame: ~Day 30: with prosthesis, 30 days post-fitting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Southampton Hand Assessment Procedure (SHAP) | 74.9 score on a scale | Standard Deviation 23.3 |
Primary
Southampton Hand Assessment Procedure (SHAP)
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.
Time frame: Day 0: no prosthesis (pre-fitting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Prosthesis, Then Prosthesis | Southampton Hand Assessment Procedure (SHAP) | 70.9 score on a scale | Standard Deviation 29.5 |