Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study
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: 13-008649
NCT ID: NCT02274532
Sponsor Protocol Number: 13-008649
About this study
A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).
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:
1) Subjects > 18 years of age.
Exclusion Criteria:
- Patients with an amputation for less than 6 months.
- Patients who have been fit and trained to use a prothesis but chose not to do so.
- Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.
5) Visual problems that would interfere with our grasp task.
6) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task
7) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.
8) Active psychiatric illness.
9) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).
10) Use of medications that might affect sensory and/or motor functions.
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 Karen Andrews, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available