Assessing Force Feedback With the SoftHand Pro
CUFF
Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
1 other identifier
interventional
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2017
CompletedFirst Submitted
Initial submission to the registry
January 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedNovember 20, 2020
November 1, 2020
1.7 years
January 21, 2018
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Conveyance of force feedback
Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro.
1 year
Improvement to device embodiment through addition of grip force feedback
Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.
1 year
Study Arms (2)
Patient
EXPERIMENTALTesting 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.
Control
OTHERTesting 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.
Interventions
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.
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kristin Zhao, PhDlead
- Arizona State Universitycollaborator
- University of Pisacollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin D. Zhao, Ph.D.
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Karen L. Andrews, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 21, 2018
First Posted
January 26, 2018
Study Start
October 17, 2017
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
November 20, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share