Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

September 4, 2015 updated by: Myomo
The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Chardon, Ohio, United States, 44024
        • Recruiting
        • GRE Chardon
        • Contact:
          • Jonathan Naft, CPO, LPO
          • Phone Number: 440-285-5785
          • Email: jnaft@greop.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over 18 years.
  • Upper limb impairment caused by any stroke (CVA)
  • Minimum of trace MMT (1/5) in Biceps and/or Triceps
  • Full Passive range of motion in elbow, forearm, wrist, and hand
  • Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
  • Score of at least 20 on the Mini Mental Status Examination.
  • Ability to read and comprehend the English language.
  • Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.

Exclusion Criteria:

  • Fixed upper limb contractures on affected side.
  • Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
  • Inability to follow three step directions.
  • Severe shoulder subluxation, pain or shoulder dislocation.
  • Passive shoulder range of motion less than 45 degrees in flexion and abduction.
  • Pain or hypersensitivity in the arm(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myoelectric Elbow-Wrist-Hand Orthosis
Device: Myoelectric Elbow-Wrist-Hand orthosis
An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.
Other Names:
  • MyoPro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time Frame: 2 hours

Assessment of sensorimotor function for the upper extremities (arms)

http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908
2 hours
Modified Ashworth Scale
Time Frame: 2 hours

Measurement of muscle spasticity due to nervous system injury or disease

http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902
2 hours
Box and Blocks Test
Time Frame: 2 hours

An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period.

http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myomo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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