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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Patient is fit with Point Digit partial hand prosthetic system
Point Designs
Lafayette, Colorado, United States
Arm Dynamics
Overland Park, Kansas, United States
Arm Dynamics
Maple Grove, Minnesota, United States
Arm Dynamics
Portland, Oregon, United States
Arm Dynamics
Philadelphia, Pennsylvania, United States
Arm Dynamics
Houston, Texas, United States
Arm Dynamics
Irving, Texas, United States
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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