CompletedNot Applicable

Assessing Force Feedback With the SoftHand Pro

United States27 participantsStarted 2017-10-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. age \> 18 years.
✓. 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)

What they're measuring

Conveyance of force feedback

Timeframe: 1 year

Improvement to device embodiment through addition of grip force feedback

Timeframe: 1 year

Trial details

NCT IDNCT03412656

SponsorKristin Zhao, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-14

View on ClinicalTrials.gov More Amputation, Traumatic trials