Myomo e100 NeuroRobotic System Home Safety Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Myomo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Myomo
ClinicalTrials.gov Identifier:
NCT00820638
First received: January 8, 2009
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Stroke
Device: myomo e100
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Myomo:

Primary Outcome Measures:
  • No reported adverse events [ Time Frame: 3 weeks of home use ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: November 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
observational
Device: myomo e100
use of the myomo e100 in home
Other Names:
  • myomo e100
  • neurorobotic system

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820638

Contacts
Contact: Janet Bostrom 617-861-4191 janet@myomo.com
Contact: Mae Doherty 6178614191 mae@myomo.com

Locations
United States, Massachusetts
Myomo Inc Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Ela    312-560-7580    ela@myomo.com   
Contact: mae doherty    617-861-4191    mae@myomo.com   
Sponsors and Collaborators
Myomo
Investigators
Principal Investigator: Richard Hughes, MSPT Myomo, Inc
  More Information

No publications provided

Responsible Party: Richard Hughes, PT, MS, Myomo, Inc
ClinicalTrials.gov Identifier: NCT00820638     History of Changes
Other Study ID Numbers: 05
Study First Received: January 8, 2009
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Myomo:
neurorobotics
occupational therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014