Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Cerebrovascular Accidents Clinical Trial

Official title:

Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544672
• Other study ID #: 15-260
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2015
• Last updated: September 4, 2015
• Start date: July 2015

Study information

• Verified date: September 2015
• Source: Myomo
• Contact: Jonathan Naft, CPO, LPO
• Phone: 440-285-5785
• Email: jnaft[@]greop.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebrovascular Accidents
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	GRE Chardon	Chardon	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Myomo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment Upper Extremity (FMA-UE)	Assessment of sensorimotor function for the upper extremities (arms); http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908	2 hours	No
Primary	Modified Ashworth Scale	Measurement of muscle spasticity due to nervous system injury or disease; http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902	2 hours	No
Primary	Box and Blocks Test	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	No