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

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Novel Prosthetic Hook; Device: Control Hook (Light Spring); Device: Control Hook (Heavy Spring)

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring); 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.
Experimental: Novel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring); 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.
Experimental: Control Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook; 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.
Experimental: Control Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook; 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.
Experimental: Control Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring); 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.
Experimental: Control Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring); 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; The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.; Device: Control Hook (Light Spring); 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.; Device: Control Hook (Heavy Spring); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clothespin Relocation Task Average Time	This is a functional hand assessment that measures the time it takes to reposition clothespins of differing stiffnesses. Lower completion times indicate better performance.	through study completion, an average of 1 day
Borg Rating of Perceived Exertion (RPE)	This is a scale of 0 to 10 with 0 indicated by the participate as a measure of how difficult a task is.	through study completion, an average of 1 day
NASA Task Load Index	The NASA Task Load Index method assesses work load. The aggregate score reported scales from 0 to 100, where 100 indicates the maximum (hardest) workload.	through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Little Room Innovations, LLC
• Collaborators: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: R43HD115423 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No