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

NCT ID: NCT07254247

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type 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), 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.

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type 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

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.

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type 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), 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,

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type 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 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.

Group Type EXPERIMENTAL

Control Hook (Light Spring)

Intervention Type 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)

Intervention Type 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.

Novel Prosthetic Hook

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Little Room Innovations, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brian Lawson, PhD

Role: CONTACT

317-691-1604

Harrison Bartlett, PhD

Role: CONTACT

205-862-0912

Facility Contacts

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Deanna Gates, PhD

Role: primary

734-647-2698

Other Identifiers

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R43HD115423

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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