Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Myomo

Status: Unknown

Conditions: Cerebrovascular Accidents

Treatments: Device: Myoelectric Elbow-Wrist-Hand orthosis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02544672

15-260

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

Myoelectric Elbow-Wrist-Hand Orthosis

Experimental group

Treatment:

Device: Myoelectric Elbow-Wrist-Hand orthosis