Upper Extremity Amputee
Conditions
Keywords
Sensory Feedback, Advanced Control, Sensorimotor feedback, Prostheses and implants
Brief summary
The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
Detailed description
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
Interventions
DEVICEiSens
The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
Sponsors
VA Office of Research and Development
United States Department of Defense
Congressionally Directed Medical Research Programs
Case Western Reserve University
University Hospitals Cleveland Medical Center
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessments will be analyzed by a blinded assessor.
Intervention model description
This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acquired upper limb amputation * Unilateral or bilateral amputation, above or below elbow * At least 6 months since time of amputation * Current user of a myoelectric prosthesis or prescribed to use one * Viable target nerves in the upper extremity * Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Exclusion criteria
* A contraindication preventing surgery * Uncontrolled diabetes * Chronic skin ulcerations * History of poor wound healing without specific cause * History of uncontrolled infection without specific cause * Active infection * Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study * Inability to speak English * Expectation that MRI will be required at any point for duration of study or while device is implanted. * Arthritis in the area of implant * Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators) * Presence of auto immune diseases, or conditions requiring immunosuppression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience Measure | 9 months post implant | Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Box and Blocks | 9 months post implant | Measuring the change in numbers of blocks moved during a timed test. |
Countries
United States
Contacts
CONTACTEmily L Graczyk, PhD
CONTACTMelissa S Schmitt
PRINCIPAL_INVESTIGATOREmily L Graczyk, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Outcome results
None listed