Assessing Force Feedback With the SoftHand Pro

Amputation, Traumatic Clinical Trial

— CUFF  

Official title:

Assessing the Effectiveness of Upper-limb Force Feedback With the SoftHand Pro Myoelectric Prosthesis in Persons With Transradial Limb Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412656
• Other study ID #: 17-005611
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: June 14, 2019

Study information

• Verified date: November 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amputation, Traumatic
• Limb Defect

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Kristin Zhao, PhD	Arizona State University, University of Pisa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials