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

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ClinicalTrials.gov Identifier: NCT04755790
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
University of Colorado, Denver
Arm Dynamics
Information provided by (Responsible Party):
Point Designs

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.

Condition or disease Intervention/treatment Phase
Amputation; Traumatic, Hand Device: Point Digit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Assess the Utility of the Point Digit in a Clinical Take-home Study
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
No Intervention: No Prosthesis
Baseline outcome measurements will be performed without a prosthesis
Experimental: 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
Device: Point Digit
Patient is fit with Point Digit partial hand prosthetic system




Primary Outcome Measures :
  1. Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) [ Time Frame: 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.

  2. Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: 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.

  3. Southampton Hand Assessment Procedure (SHAP) [ Time Frame: 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.

  4. EuroQol-5 Dimension (EQ-5D-5L) [ Time Frame: 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.

  5. Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) [ Time Frame: Day 0: with prosthesis, immediately post-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.

  6. Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: Day 0: with prosthesis, immediately post-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.

  7. Southampton Hand Assessment Procedure (SHAP) [ Time Frame: Day 0: with prosthesis, immediately post-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.

  8. EuroQol-5 Dimension (EQ-5D-5L) [ Time Frame: Day 0: with prosthesis, immediately post-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.

  9. Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) [ Time Frame: ~Day 30: with prosthesis, 30 days post-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.

  10. Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: ~Day 30: with prosthesis, 30 days post-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.

  11. Southampton Hand Assessment Procedure (SHAP) [ Time Frame: ~Day 30: with prosthesis, 30 days post-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.

  12. EuroQol-5 Dimension (EQ-5D-5L) [ Time Frame: ~Day 30: with prosthesis, 30 days post-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.

  13. Capacity Assessment of Prosthetic Performance for the Upper Limb (CAPPFUL) [ Time Frame: ~Day 60: with prosthesis, 60 days post-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.

  14. Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: ~Day 60: with prosthesis, 60 days post-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.

  15. Southampton Hand Assessment Procedure (SHAP) [ Time Frame: ~Day 60: with prosthesis, 60 days post-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.

  16. EuroQol-5 Dimension (EQ-5D-5L) [ Time Frame: ~Day 60: with prosthesis, 60 days post-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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755790


Contacts
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Contact: Levin Sliker, PhD 7206004753 levin@pointdesignsllc.com

Locations
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United States, Colorado
Point Designs Recruiting
Lafayette, Colorado, United States, 80026
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
United States, Kansas
Arm Dynamics Recruiting
Overland Park, Kansas, United States, 66209
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
United States, Minnesota
Arm Dynamics Recruiting
Maple Grove, Minnesota, United States, 55369
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
United States, Oregon
Arm Dynamics Recruiting
Portland, Oregon, United States, 97223
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
United States, Pennsylvania
Arm Dynamics Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
United States, Texas
Arm Dynamics Recruiting
Houston, Texas, United States, 77004
Contact: Levin Sliker, PhD    720-600-4753    levin@pointdesignsllc.com   
Arm Dynamics Recruiting
Irving, Texas, United States, 75062
Contact: Levin Sliker, PhD    720-600-4753    lein@pointdesignsllc.com   
Sponsors and Collaborators
Point Designs
University of Colorado, Denver
Arm Dynamics
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Responsible Party: Point Designs
ClinicalTrials.gov Identifier: NCT04755790    
Other Study ID Numbers: 253924
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Amputation, Traumatic
Wounds and Injuries