Wearable Robotic Functional Assistance for Stroke Rehabilitation

• Sponsor: Myomo (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00396708
• Collaborator: (none)
• Enrollment: 20
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
CVA (Cerebrovascular Accident)	Device: myomo e100 neurorobotic elbow brace	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2006
• Actual Primary Completion Date: Dec 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	myomo Inc.	Boston	Massachusetts	United States	02129

Sponsors and Collaborators

• Myomo

Investigators

• Principal Investigator: Kailas N Narendran, BS, MEng, Inventor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Myomo Inc. Homepage

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00396708
• Other Study ID Numbers: 1
• First Posted: Nov 7, 2006
• Last Update Posted: Feb 3, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: Robotics; Rehabilitation; Arm; Stroke; Weakness; Outpatient; Chronic
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Feb 3, 2010