Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study (SoftHand)

A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).

Study Overview

• Status: Completed
• Conditions: Upper Limb Amputation Below Elbow (Injury)
• Intervention / Treatment: Device: SoftHand

Detailed Description

Preliminary data suggest that the SoftHand Pro (SHpro) is extremely versatile and can be used to grasp and manipulate common objects. We will perform extensive testing of the myoelectric SHpro by asking subjects to perform a wide variety of ADL tasks in a structured environment onsite at Mayo Clinic Rochester. These data will be used by the Mayo Clinic, ASU, and the IIT research teams to modify the SHpro design to adapt it for use by people with amputations while focusing on the SHpro socket design, surface electromyography (EMG)-based control (typically used in commercially available prostheses today).

We will quantify the ability of patients with below-elbow amputation to perform the above tasks using the prosthetic terminal device version of the SHpro. We hypothesize that people with amputations will learn to use the SHpro and perform grasp and manipulation tasks to a greater level than that allowed by their current terminal devices.

The long-term objectives of this exploratory study are to design and build a low-cost, high-performance prosthetic hand terminal device that will be accepted by patients with below-elbow amputation and allow them to perform a wider range of ADL tasks than allowed by today's commercially available prostheses. The data collected through the proposed studies will provide an important foundation for optimizing the design of the SHpro for future testing on a large number of people with limb loss. Future studies will also assess the extent to which the SHpro's functionality and acceptance might benefit from embedding additional synergistic hand motion patterns in the SHpro.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1) Subjects > 18 years of age.

Exclusion Criteria:

1. Patients with an amputation for less than 6 months.
2. Patients who have been fit and trained to use a prothesis but chose not to do so.
3. Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.

5) Visual problems that would interfere with our grasp task.

6) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task

7) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.

8) Active psychiatric illness.

9) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).

10) Use of medications that might affect sensory and/or motor functions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient; Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 5 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability, with the option with patients for a 1-week period of take-home testing and associated pre- and post-assessments.	Device: SoftHand; Biomechanical, ADL, and functional testing.; Other Names: SH; SHpro
Other: Control; Testing will include self-report questionnaires, assessments of activities of daily living (ADL) by an occupational therapist, and biomechanical measures of forces applied to objects and motion of the upper limb collected during commonly-performed tasks. Motion will be recorded using sensors that are attached to the arm and SoftHand. During each session, videos will be obtained of the subjects performing tasks. The experimental data collections are organized into 4 Sessions, which will take place over the course of 1 week, scheduled by the subject's availability. Control subjects will participate in two sessions, including a pre- and post-training assessments.	Device: SoftHand; Biomechanical, ADL, and functional testing.; Other Names: SH; SHpro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional assessments	DASH score, the Jebsen Taylor Test of Hand Function, and biomechanical measures (including total grip force, load force sharing between the thumb and finger(s), time to peak grip force, and net torque exerted by the subject at object lift onset).	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADL tests	The AM-ULA ADL assessment will be used as secondary outcome measures to identify specific grasping tasks or task component(s) that a control or people with amputations subject might have difficulty performing.	1 week

Collaborators and Investigators

• Sponsor: Karen L. Andrews, M.D.
• Collaborators: University of Pisa; Arizona State University
• Investigators: Principal Investigator: Karen L. Andrews, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2014
• Primary Completion (Actual): May 17, 2016
• Study Completion (Actual): May 17, 2016

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 13-008649

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No