Evaluation of Dexterous Terminal Device

NCT05840601 | Withdrawn FDA Device

• 1 other identifier: 271065
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.

Conditions

Amputation; Amputation, Traumatic; Amputation; Traumatic, Hand; Limb; Absence, Congenital, Upper; Prosthesis User; Upper Limb Amputation Below Elbow (Injury); Upper Limb Amputation At the Hand

Keywords

amputee; upper limb amputee; upper limb prosthesis user; prosthesis; upper limb absence; dexterous fingertip; index finger prosthesis

Outcome Measures

Primary Outcomes (1)

• Jebsen-Taylor Small Common Objects Functional Test

  During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. This test will be used to evaluate the feasibility of the device design as compared with the unmodified prosthetic hand.

  4 hours

Secondary Outcomes (1)

• User Feedback

  4 hours

Study Arms (2)

Pointdexter

EXPERIMENTAL

The investigational device being tested is Pointdexter, a novel prosthetic finger with a built-in split gripper. The device is an index finger which can drop in place of existing fingers on a prosthetic hand. The investigational device is controlled with the same signals used to control the hand. Participants will use a commercially available prosthetic hand compatible with the Pointdexter device for this study.

Device: Pointdexter

Comparator

ACTIVE COMPARATOR

The comparator device is the same commercially available hand that is being used for the Pointdexter arm, except that it will be unmodified (i.e., it will have its usual index finger attached instead of the Pointdexter finger).

Device: Comparator

Interventions

Pointdexter DEVICE

Commercially available prosthetic hand modified with the investigational Pointdexter finger in place of the usual index finger.

Also known as: Dexterous Terminal Device

Pointdexter

Comparator DEVICE

Unmodified commercially available prosthetic hand.

Comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an upper limb absence
• Uses myoelectric control for their prosthesis
• If they have a major upper limb absence, must use a quick-disconnect wrist
• If able-bodied, must be willing to use an upper-limb prosthesis bypass for testing
• Willing and able to complete activities outlined in the study and provide requested feedback.
• Adults must be able to provide their own consent.

You may not qualify if:

• The risks to pregnant people and fetuses are unknown and therefore those who are pregnant should not participate in the study and will be screened by self-disclosure.

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead

Related Links

• Presentation - Initial Clinical Evaluation of Pointdexter - A Dexterous Prosthetic Fingertip

MeSH Terms

Conditions

Amputation, Traumatic; Wounds and Injuries

Study Design

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

Model Details: In the lab, a functional test will be used to evaluate the feasibility of the device design as compared with a baseline condition. A subset of these subjects will test the investigational device at home for up to 2 weeks to provide feedback on the investigational device when used in everyday tasks.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: December 22, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share