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Wearable Robotic Functional Assistance for Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT00396708
Recruitment Status : Completed
First Posted : November 7, 2006
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Myomo

Brief Summary:
This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

Condition or disease Intervention/treatment Phase
CVA (Cerebrovascular Accident) Device: myomo e100 neurorobotic elbow brace Not Applicable

Detailed Description:

This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.

The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.

Study procedures will focus on performing functional tasks using the e100.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wearable Robotic Functional Assistance for Stroke Rehabilitation
Study Start Date : August 2006
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Motor Activity Log
  2. Fugl-Meyer Upper Arm Function
  3. Wolf Motor Function
  4. SF-36 QOL Survey
  5. Range of Motion
  6. Muscle Strength Test


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Medically Stable
  • Cognitive Awareness
  • Weakness in upper arm
  • Over 1 year post CVA
  • not engaged in any other upper arm therapies

Exclusion Criteria:

  • Rashes, open wounds or skin sensitivity on arm
  • Very high elbow tone (arm rigid in flexion or extension)

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 ClinicalTrials.gov identifier (NCT number): NCT00396708


Locations
United States, Massachusetts
myomo Inc.
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Myomo
Investigators
Principal Investigator: Kailas N Narendran, BS, MEng Inventor

Additional Information:
Responsible Party: Kailas Narendran, Myomo,Inc
ClinicalTrials.gov Identifier: NCT00396708     History of Changes
Other Study ID Numbers: 1
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by Myomo:
Robotics
Rehabilitation
Arm
Stroke
Weakness
Outpatient
Chronic

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