search
Back to results

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
Myomo
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 3, 2006
Last Updated
February 2, 2010
Sponsor
Myomo
search

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