Dexterous Partial Hand Prosthesis Outcomes

NCT05038566 | Completed Results FDA Device

• 1 other identifier: 20212193
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.

Conditions

Amputation; Amputation; Traumatic, Hand; Limb; Absence, Congenital, Upper; Prosthesis User; Upper Limb Amputation at the Hand

Keywords

amputee; upper limb amputee; partial hand prosthesis user; prosthesis; i-Digits; upper limb loss; prosthetist; gripper; 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. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition. This was the only primary outcome measure collected for this study. There were no secondary outcome measures, only exploratory measures as this is a very early prototype design that is still in the design iteration stages.

  4 hours at a single site visit

Study Arms (2)

Comparator Baseline

NO INTERVENTION

The subject's usual partial hand prosthesis

Pointdexter

EXPERIMENTAL

The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device.

Device: Pointdexter

Interventions

Pointdexter DEVICE

i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.

Also known as: Dexterous Partial Hand Prosthesis, Gripper

Pointdexter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have an upper limb partial hand absence.
• Must be new or current i-Digits prosthesis users.
• Must have an absent index finger at minimum.
• Must be able to understand spoken and written English in order to be properly consented and provide feedback to the study personnel.
• Must be willing and able to complete outlined tasks and provide feedback on the intervention.

You may not qualify if:

• The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study.

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead
• Össur Iceland ehf: collaborator

Study Sites (2)

Liberating Technologies, Inc.

Holliston, Massachusetts, 01746, United States

Location

Össur Academy - Touch Solutions

Dublin, Ohio, 43017, United States

Location

Results Point of Contact

• Title: Dr. Todd Farrell
• Organization: Liberating Technologies, Inc.

todd.farrell@liberatingtech.com

774-233-0873

Study Officials

• Todd Farrell, PhD

  Liberating Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Functional tests will be used to evaluate the feasibility of the device design as compared with the subject's baseline device.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: September 9, 2021
• Study Start: July 15, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)