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To Assess the Utility of the Point Digit in a Clinical Take-home Study

Primary Purpose

Amputation; Traumatic, Hand

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point Digit
Sponsored by
Point Designs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amputation; Traumatic, Hand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Point Designs
  • Arm Dynamics
  • Arm Dynamics
  • Arm Dynamics
  • Arm Dynamics
  • Arm Dynamics
  • Arm Dynamics

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Prosthesis

Prosthesis

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
September 26, 2022
Sponsor
Point Designs
Collaborators
University of Colorado, Denver, Arm Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT04755790
Brief Title
To Assess the Utility of the Point Digit in a Clinical Take-home Study
Official Title
To Assess the Utility of the Point Digit in a Clinical Take-home Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
August 9, 2022 (Actual)
Study Completion Date
August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Point Designs
Collaborators
University of Colorado, Denver, Arm Dynamics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Hand

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Prosthesis
Arm Type
No Intervention
Arm Description
Baseline outcome measurements will be performed without a prosthesis
Arm Title
Prosthesis
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Point Digit
Intervention Description
Patient is fit with Point Digit partial hand prosthetic system
Primary Outcome Measure Information:
Title
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
Description
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)
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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)
Title
Southampton Hand Assessment Procedure (SHAP)
Description
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)
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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)
Title
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
Description
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
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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
Title
Southampton Hand Assessment Procedure (SHAP)
Description
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
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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
Title
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
Description
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
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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
Title
Southampton Hand Assessment Procedure (SHAP)
Description
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
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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
Title
Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL)
Description
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
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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
Title
Southampton Hand Assessment Procedure (SHAP)
Description
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
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Point Designs
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Arm Dynamics
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Arm Dynamics
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Arm Dynamics
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Arm Dynamics
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Arm Dynamics
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Arm Dynamics
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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To Assess the Utility of the Point Digit in a Clinical Take-home Study

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