A Study to Assess Force Feedback with the SoftHand Pro
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-005611
NCT ID: NCT03412656
Sponsor Protocol Number: 17-005611
About this study
The purpose of this study is to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with upper extremity limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age > 18 years old.
- No prior experience with the CUFF device.
- History of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
Exclusion Criteria:
- Amputation for less than 6 months.
- Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy.
- Orthopedic, joint degeneration (i.e., arthritis, verified by x-ray) affecting the hand or cervical spine that severely limit upper limb function.
- Visual problems that would interfere with the grasp task.
- 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.
- Significant rigidity as assessed through range of motion testing.
- Active psychiatric illness.
- Significant cognitive impairments (a score < 24 on the Mini-Mental State Examination; non-control subjects only).
- Use of medications that might affect sensory and/or motor functions.
- Inability to effectively control myoelectrics for study purposes (control subjects only).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kristin Zhao, Ph.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available