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

Little Room Innovations, LLC

Status: Enrolling

Conditions: Amputation

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07254247

R43HD115423 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)

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

Experimental group

Description:

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.

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)

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

Experimental group

Description:

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.

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)

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

Experimental group

Description:

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.

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)

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

Experimental group

Description:

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,

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)

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

Experimental group

Description:

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.

Treatment:

Device: Novel Prosthetic Hook

Device: Control Hook (Heavy Spring)

Device: Control Hook (Light Spring)