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

Amputation; Traumatic, Hand Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755790
• Other study ID #: 253924
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Point Designs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Hand

Intervention

Device:
• Point Digit
Patient is fit with Point Digit partial hand prosthetic system

Locations

Country	Name	City	State
United States	Arm Dynamics	Houston	Texas
United States	Arm Dynamics	Irving	Texas
United States	Point Designs	Lafayette	Colorado
United States	Arm Dynamics	Maple Grove	Minnesota
United States	Arm Dynamics	Overland Park	Kansas
United States	Arm Dynamics	Philadelphia	Pennsylvania
United States	Arm Dynamics	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Point Designs	Arm Dynamics, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 0: no prosthesis (pre-fitting)
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.	Day 0: no prosthesis (pre-fitting)
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.	Day 0: no prosthesis (pre-fitting)
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.	Day 0: no prosthesis (pre-fitting)
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.	Day 0: with prosthesis, immediately post-fitting
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.	Day 0: with prosthesis, immediately post-fitting
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.	Day 0: with prosthesis, immediately post-fitting
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.	Day 0: with prosthesis, immediately post-fitting
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.	~Day 30: with prosthesis, 30 days post-fitting
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.	~Day 30: with prosthesis, 30 days post-fitting
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.	~Day 30: with prosthesis, 30 days post-fitting
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.	~Day 30: with prosthesis, 30 days post-fitting
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.	~Day 60: with prosthesis, 60 days post-fitting
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.	~Day 60: with prosthesis, 60 days post-fitting
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.	~Day 60: with prosthesis, 60 days post-fitting
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.	~Day 60: with prosthesis, 60 days post-fitting