Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Not Applicable

• Conditions: Cerebrovascular Accidents
• Interventions: Device: Myoelectric Elbow-Wrist-Hand orthosis

• Registration Number: NCT02544672
• Lead Sponsor: Myomo

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).

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 Timeline

• Study Start: 2015-07
• Status Verified: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-04
• Last Update Submitted: 2015-09-04
• Study First Posted: 2015-09-09
• Last Update Posted: 2015-09-09
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myoelectric Elbow-Wrist-Hand Orthosis	Myoelectric Elbow-Wrist-Hand orthosis	-

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

GRE Chardon; 🇺🇸 Chardon, Ohio, United States