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OpenTrials
Completed

NCT Number: NCT07254247

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.

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Key information

Conditions

Amputation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 (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)

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.

Primary outcomes

  1. Modified SHAP Average Completion Time

    Time frame: through study completion, an average of 1 day

    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.

Secondary outcomes

  1. Clothespin Relocation Task Average Time

    Time frame: through study completion, an average of 1 day

    This is a functional hand assessment that measures the time it takes to reposition clothespins of differing stiffnesses. Lower completion times indicate better performance.

  2. Borg Rating of Perceived Exertion (RPE)

    Time frame: through study completion, an average of 1 day

    This is a scale of 0 to 10 with 0 indicated by the participate as a measure of how difficult a task is.

  3. NASA Task Load Index

    Time frame: through study completion, an average of 1 day

    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.

Sponsors and collaborators

Lead sponsor

Little Room Innovations, LLC

Industry

Collaborators

  • University of Michigan

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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