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Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Sponsor
Myomo (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02544672
Collaborator
(none)
30
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Myoelectric Elbow-Wrist-Hand orthosis
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jul 1, 2016

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fugl-Meyer Assessment Upper Extremity (FMA-UE) [2 hours]

      Assessment of sensorimotor function for the upper extremities (arms) http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908

    2. Modified Ashworth Scale [2 hours]

      Measurement of muscle spasticity due to nervous system injury or disease http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902

    3. Box and Blocks Test [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GRE Chardon Chardon Ohio United States 44024

    Sponsors and Collaborators

    • Myomo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myomo
    ClinicalTrials.gov Identifier:
    NCT02544672
    Other Study ID Numbers:
    • 15-260
    First Posted:
    Sep 9, 2015
    Last Update Posted:
    Sep 9, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Sep 9, 2015