Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
| Registry | NCT03412656, acronym CUFF |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, device feasibility |
| Enrollment | 27 (Actual) |
| Sponsor | Kristin Zhao, PhD (Other); collaborators: Arizona State University, University of Pisa |
| Conditions | Amputation, Traumatic, Limb Defect |
| Interventions | SoftHand Pro with CUFF force feedback device (Device) |
| Dates | start 2017-10-17, primary completion 2019-06-14, completion 2019-06-14, first posted 2018-01-26, last updated 2020-11-20 |
| Locations | 1 site in United States |
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All trials for Amputation, Traumatic All trials for Limb Defect All trials of SoftHand Pro with CUFF force feedback device
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patient | Experimental | Device: SoftHand Pro with CUFF force feedback device | Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing the subjects' own prosthetic sockets. Grip force will be recorded using sensors attached to the CUFF device. During each session, videos will be obtained of the subjects performing tasks for kinematics analysis. The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability. |
| Control | Other | Device: SoftHand Pro with CUFF force feedback device | Testing will include assessments of activities of daily living (ADLs) by a physical therapist, biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks, and surveys assessing user preference regarding the force feedback feature, all while using the SoftHand Pro myoelectric lower arm prosthetic and the CUFF force feedback devices in tandem, utilizing an adapter simulating a prosthetic socket. Grip force will be recorded using sensors attached to the CUFF device. During each session, videos will be obtained of the subjects performing tasks for kinematics analysis. The experimental sessions are organized into one to two sessions, comprising up to 16 hours, as determined by subject availability. |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic in Rochester | Rochester, Minnesota | United States |