Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
Launched by MYOMO · Sep 4, 2015
Trial Information
Current as of August 02, 2025
Unknown status
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- 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)
About Myomo
Myomo is a pioneering medical technology company dedicated to improving the lives of individuals with neuromuscular disorders through innovative wearable robotic devices. Specializing in the development of myoelectric orthoses, Myomo's products are designed to restore mobility and enhance functionality for patients with conditions such as stroke, spinal cord injury, and other debilitating diseases. The company’s commitment to research and clinical trials underscores its focus on advancing the efficacy and safety of its solutions, aiming to provide patients with greater independence and improved quality of life. With a strong emphasis on patient-centered design and cutting-edge technology, Myomo is at the forefront of transforming rehabilitation and mobility solutions in the healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chardon, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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