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

NCT04755790 | Completed Results FDA Device

• 1 other identifier: 253924
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 7

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.

Conditions

Amputation; Traumatic, Hand

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  ~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.

  ~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.

  ~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.

  ~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.

  ~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.

  ~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.

  ~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.

  ~Day 60: with prosthesis, 60 days post-fitting

Study Arms (2)

No Prosthesis

NO INTERVENTION

Baseline outcome measurements will be performed without a prosthesis

Prosthesis

EXPERIMENTAL

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

Interventions

Point Digit DEVICE

Patient is fit with Point Digit partial hand prosthetic system

Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Point Designs: lead
• University of Colorado, Denver: collaborator
• Arm Dynamics: collaborator

Study Sites (7)

Point Designs

Lafayette, Colorado, 80026, United States

Location

Arm Dynamics

Overland Park, Kansas, 66209, United States

Location

Arm Dynamics

Maple Grove, Minnesota, 55369, United States

Location

Arm Dynamics

Portland, Oregon, 97223, United States

Location

Arm Dynamics

Philadelphia, Pennsylvania, 19146, United States

Location

Arm Dynamics

Houston, Texas, 77004, United States

Location

Arm Dynamics

Irving, Texas, 75062, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Point Designs

research@pointdesignsllc.com

7206004753

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: February 16, 2021
• Study Start: May 18, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)