Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2017-10-17
2019-06-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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Patient
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.
SoftHand Pro with CUFF force feedback device
Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
Control
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.
SoftHand Pro with CUFF force feedback device
Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
Interventions
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SoftHand Pro with CUFF force feedback device
Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. no prior experience with the CUFF device.
3. history of elbow disarticulation, transradial, or transhumeral limb loss (non-control subjects only).
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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Arizona State University
OTHER
University of Pisa
OTHER
Kristin Zhao, PhD
OTHER
Responsible Party
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Kristin Zhao, PhD
Principal Investigator
Principal Investigators
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Kristin D. Zhao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Karen L. Andrews, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-005611
Identifier Type: -
Identifier Source: org_study_id