- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396708
Wearable Robotic Functional Assistance for Stroke Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02129
- Myomo Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Motor Activity Log
|
Fugl-Meyer Upper Arm Function
|
Wolf Motor Function
|
SF-36 QOL Survey
|
Range of Motion
|
Muscle Strength Test
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kailas N Narendran, BS, MEng, Inventor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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