Amputation
Conditions
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.
Interventions
DEVICENovel Prosthetic Hook
The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device.
DEVICEControl 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.
DEVICEControl 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.
Sponsors
Little Room Innovations, LLC
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified SHAP Average Completion Time | 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
| Measure | Time frame | Description |
|---|---|---|
| Clothespin Relocation Task Average Time | 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. |
| Borg Rating of Perceived Exertion (RPE) | 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. |
| NASA Task Load Index | 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. |
Countries
United States
Outcome results
None listed