Amputation, Traumatic, Limb Defect
Conditions
Keywords
CUFF, Soft Hand Pro, SHP, SH Pro, SoftHand
Brief summary
The trial is designed to test the effectiveness of a force-feedback cuff in combination with a myoelectric prosthesis in conveying information on grasp strength to the user, as well as the user's preference regarding the feature.
Detailed description
The human sensorimotor control system uses both feedforward planning and sensory feedback information, in order to actuate the musculoskeletal system and interact with the external environment, e.g. when modulating grip force for various object properties. As a result, lack of sensory input, as in the case of motor impairments or amputations, can dramatically affect activities of daily living (ADLs). The contribution of the proposed research will be to test the effectiveness of a novel, non-invasive prosthetic technology in delivering sensory information. The investigators' approach is modality matching, in that it produces a sensation in the user similar to the type of information to be transmitted. Specifically, the approach will combine the Soft Hand Pro (SHP), an anthropomorphic, myoelectrically controlled prosthetic hand, with an upper limb force feedback device (CUFF) to provide patients with transradial amputations with grasp force (pressure) information.
Interventions
DEVICESoftHand Pro with CUFF force feedback device
Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
Sponsors
University of Pisa
Arizona State University
Kristin Zhao, PhD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age \> 18 years. 2. no prior experience with the CUFF device. 3. history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
Exclusion criteria
1. amputation for less than 6 months 2. clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy 3. orthopedic, joint degeneration (i.e., arthritis, verified by x-ray) affecting the hand or cervical spine that severely limit upper limb function 4. visual problems that would interfere with the grasp task 5. co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) revealed in medical history 6. significant rigidity as assessed through range of motion testing 7. active psychiatric illness 8. significant cognitive impairments (a score \< 24 on the Mini-Mental State Examination) 9. use of medications that might affect sensory and/or motor functions 10. inability to effectively control myoelectrics for study purposes (control subjects only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conveyance of force feedback | 1 year | Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro. |
| Improvement to device embodiment through addition of grip force feedback | 1 year | Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro. |
Countries
United States
Outcome results
None listed