Wearable Robotic Functional Assistance for Stroke Rehabilitation
Primary Purpose
CVA (Cerebrovascular Accident)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
myomo e100 neurorobotic elbow brace
Sponsored by

About this trial
This is an interventional treatment trial for CVA (Cerebrovascular Accident) focused on measuring Robotics, Rehabilitation, Arm, Stroke, Weakness, Outpatient, Chronic
Eligibility 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)
Sites / Locations
- myomo Inc.
Outcomes
Primary Outcome Measures
Motor Activity Log
Fugl-Meyer Upper Arm Function
Wolf Motor Function
SF-36 QOL Survey
Range of Motion
Muscle Strength Test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00396708
Brief Title
Wearable Robotic Functional Assistance for Stroke Rehabilitation
Official Title
Wearable Robotic Functional Assistance for Stroke Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Myomo
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident)
Keywords
Robotics, Rehabilitation, Arm, Stroke, Weakness, Outpatient, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
myomo e100 neurorobotic elbow brace
Primary Outcome Measure Information:
Title
Motor Activity Log
Title
Fugl-Meyer Upper Arm Function
Title
Wolf Motor Function
Title
SF-36 QOL Survey
Title
Range of Motion
Title
Muscle Strength Test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kailas N Narendran, BS, MEng
Organizational Affiliation
Inventor
Official's Role
Principal Investigator
Facility Information:
Facility Name
myomo Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.myomo.com/
Description
Myomo Inc. Homepage
Learn more about this trial
Wearable Robotic Functional Assistance for Stroke Rehabilitation
We'll reach out to this number within 24 hrs