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

Upper Limb Amputation Below Elbow (Injury) Clinical Trial

— SoftHand  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274532
• Other study ID #: 13-008649
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: January 16, 2018
• Start date: October 24, 2014
• Est. completion date: May 17, 2016

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 17, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Upper Limb Amputation Below Elbow (Injury)

Intervention

Device:
• SoftHand
Biomechanical, ADL, and functional testing.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Karen L. Andrews, M.D.	Arizona State University, University of Pisa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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