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Assessing Force Feedback With the SoftHand Pro (CUFF)

Primary Purpose

Amputation, Traumatic, Limb Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SoftHand Pro with CUFF force feedback device
Sponsored by
Kristin Zhao, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputation, Traumatic focused on measuring CUFF, Soft Hand Pro, SHP, SH Pro, SoftHand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. amputation for less than 6 months
  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)

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2018
Last Updated
November 18, 2020
Sponsor
Kristin Zhao, PhD
Collaborators
Arizona State University, University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT03412656
Brief Title
Assessing Force Feedback With the SoftHand Pro
Acronym
CUFF
Official Title
Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
Collaborators
Arizona State University, University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The human sensorimotor control system uses both feedforward planning and sensory feedback information, in order to actuate the musculoskeletal system and interact with the external environment, e.g. when modulating grip force for various object properties. As a result, lack of sensory input, as in the case of motor impairments or amputations, can dramatically affect activities of daily living (ADLs). The contribution of the proposed research will be to test the effectiveness of a novel, non-invasive prosthetic technology in delivering sensory information. The investigators' approach is "modality matching," in that it produces a sensation in the user similar to the type of information to be transmitted. Specifically, the approach will combine the Soft Hand Pro (SHP), an anthropomorphic, myoelectrically controlled prosthetic hand, with an upper limb force feedback device (CUFF) to provide patients with transradial amputations with grasp force (pressure) information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Traumatic, Limb Defect
Keywords
CUFF, Soft Hand Pro, SHP, SH Pro, SoftHand

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SoftHand Pro with CUFF force feedback device
Other Intervention Name(s)
SoftHand, SoftHand Pro, CUFF, SHpro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conveyance of force feedback
Description
Assessments will measure the extent to which the CUFF device conveys haptic force feedback, when used in combination with the Soft Hand Pro.
Time Frame
1 year
Title
Improvement to device embodiment through addition of grip force feedback
Description
Assessments will determine any improvement of device embodiment from the addition of grip force feedback to the Soft Hand Pro.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) use of medications that might affect sensory and/or motor functions inability to effectively control myoelectrics for study purposes (control subjects only)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen L. Andrews, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Assessing Force Feedback With the SoftHand Pro

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