Assessing Force Feedback With the SoftHand Pro

Completed · Not applicable

Conditions studied: Amputation, Traumatic, Limb Defect

In brief

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.

Key facts

Study ID

NCT03412656

Run by

Kristin Zhao, PhD

People needed

27

Starts

2017-10-17

Expected to finish

2019-06-14

Last updated by the study team

2020-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age > 18 years.
• no prior experience with the CUFF device.
• history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).

You may not qualify if…

• 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)
• use of medications that might affect sensory and/or motor functions
• inability to effectively control myoelectrics for study purposes (control subjects only)

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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