A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss

NCT07254247 | Completed

• 1 other identifier: R43HD115423
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• Modified SHAP Average Completion Time

  This is the average task completion time across all tasks performed in a modified version of the Southampton Hand Assessment Protocol (SHAP). The SHAP has been modified in this study to include only the relevant assessments to the prosthetic hooks being tested. A lower average score indicates better performance.

  through study completion, an average of 1 day

Secondary Outcomes (3)

• Clothespin Relocation Task Average Time

  through study completion, an average of 1 day

• Borg Rating of Perceived Exertion (RPE)

  through study completion, an average of 1 day

• NASA Task Load Index

  through study completion, an average of 1 day

Study Arms (6)

Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring)

EXPERIMENTAL

In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a light return spring, then the Control Hook with a heavy return spring.

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring)

EXPERIMENTAL

In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a heavy return spring, then the Control Hook with a light return spring.

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook

EXPERIMENTAL

In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Control Hook with a heavy return spring, and then the Novel Prosthetic Hook.

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook

EXPERIMENTAL

In this arm, participants will first complete the tests with the Control Hook with a heavy return spring, then the Control Hook with a light return spring, and then the Novel Prosthetic Hook.

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring)

EXPERIMENTAL

In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Novel Prosthetic Hook, and then the Control Hook with a heavy return spring,

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring)

EXPERIMENTAL

In this arm, participants will first complete the tests with the the Control Hook with a heavy return spring, then Novel Prosthetic Hook, and then the Control Hook with a light return spring.

Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

Interventions

Novel Prosthetic Hook DEVICE

The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.

Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook; Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring); Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook; Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring); Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring); Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring)

Control Hook (Light Spring) DEVICE

The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring.

Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook; Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring); Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook; Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring); Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring); Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring)

Control Hook (Heavy Spring) DEVICE

The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring.

Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook; Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring); Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook; Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring); Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring); Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 18-80 Are proficient in English Able to demonstrate proper functioning and safety of the terminal device

You may not qualify if:

• Have visual or mental impairments Have history of neurological or musculoskeletal disorders

Sponsors & Collaborators

• Little Room Innovations, LLC: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: November 28, 2025
• Study Start: November 20, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)