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Myomo e100 NeuroRobotic System Home Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820638
Recruitment Status : Unknown
Verified January 2009 by Myomo.
Recruitment status was:  Recruiting
First Posted : January 12, 2009
Last Update Posted : January 12, 2009
Information provided by:

Brief Summary:
Up to 25 subjects will use the Myomoe100 in the home setting under the distant supervision of an occupational therapist. We will look to see if they can perform functional activities safely without adverse events.

Condition or disease Intervention/treatment Phase
Stroke Device: myomo e100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Myomo NeuroRobotic System Home Safety Study For Use by Stroke Survivors for Upper Extremity Rehabilitation in Their Homes
Study Start Date : November 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1
Device: myomo e100
use of the myomo e100 in home
Other Name: neurorobotic system

Primary Outcome Measures :
  1. No reported adverse events [ Time Frame: 3 weeks of home use ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion criteria:

  • Male or female over the age of 18 who experienced no more than one ischemic or hemorrhagic stroke, at least 6 months ago resulting in hemiparesis in one upper extremity
  • Upper extremity Fugl Meyer score >10- - subject must score at least a 10 on the UE FM at the baseline screening appointment only.
  • Moderate to Low Tone (Modified Ashworth Score <= 3) If there is too much background contraction in the arm, the system will be unable to pick up voluntary contraction from the background noise, and the brace may not be strong enough to counter the muscle tone. Subject's Modified Ashworth at the screening evaluation score should be < 3
  • Considered medically stable- medical conditions that are not under control may affect the subject's ability to participate in treatment sessions safely.
  • Able to participate in 17 one hour treatment sessions and willing to complete the evaluations- subjects must be willing to attend all evaluation and treatment sessions
  • Score < 3 rating of shoulder pain on the visual analog scale (Appendix N) - subjects must be able to safely tolerate the weight of the brace (about 2 lbs) during treatment sessions.
  • Brace fits on arm properly and without discomfort (No red marks or discomfort observed in 10 minutes of use)- subjects need to be able to tolerate sessions with the device
  • There is a detectable EMG signal in bicep and tricep and the subject is able to use the brace volitionally- Some voluntary muscle activity must exist for the system to be controlled by the subject due to the non-invasive, surface EMG, sensing methodology.

Exclusion Criteria:

  • A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment - Subjects must be able to tolerate a 45 minute upper-extremity therapy session in order to participate.
  • History of neurological disorder other than stroke- other neurological disorders may affect the upper extremity motor performance of subjects.
  • Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace - While wearing the brace, the system is pressed close to the upper arm and strapped around it. If the subject suffers from dermal breakdown or other skin conditions that may be aggravated by such a situation, they should not be involved in the study.
  • Substantial contracture of elbow - The system cannot work in the presence of reduced range of motion due to contractures. A substantial contracture is defined as greater than 20 degrees of elbow flexion contracture measured at the baseline evaluation.
  • Severe sensory loss: Score of 2 on the NIH stroke scale for sensory impairment. The system can work on subjects with sensory loss, however the concern is that a subject with severe sensory loss would not know if the system was applying too much force to the arm or if a strap was too tight and therefore not be able to inform their clinician.
  • Use of Botox injections in shoulder, arm or hand for the 3 months prior to study start and throughout the duration of the research study. - the use of Botox may alter the subject's performance on upper extremity motor tasks that are being assessed in the research
  • Cognitive or perceptual deficits sufficiently severe enough to interfere with ability to follow instructions- If the subject is unable to understand and follow simple instructions or express if the presence of pain, they should not be included. If the subject scores <69 on the Modified Mini Mental Exam or, if in the opinion of the principle investigator the subject can not safely participate in the study, the subject will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820638

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Contact: Janet Bostrom 617-861-4191
Contact: Mae Doherty 6178614191

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United States, Massachusetts
Myomo Inc Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Ela    312-560-7580   
Contact: mae doherty    617-861-4191   
Sponsors and Collaborators
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Principal Investigator: Richard Hughes, MSPT Myomo Inc.
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Responsible Party: Richard Hughes, PT, MS, Myomo, Inc Identifier: NCT00820638    
Other Study ID Numbers: 05
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009
Keywords provided by Myomo:
occupational therapy
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases