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NCT00396708 Clinical Trial

Wearable Robotic Functional Assistance for Stroke Rehabilitation

CVA (Cerebrovascular Accident) Clinical Trial

Official title:
Wearable Robotic Functional Assistance for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00396708
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received November 3, 2006
Last updated February 2, 2010
Start date August 2006

Study information
Verified date February 2010
Source Myomo
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• myomo e100 neurorobotic elbow brace

Locations
Country Name City State
United States myomo Inc. Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Myomo

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Motor Activity Log
Primary Fugl-Meyer Upper Arm Function
Primary Wolf Motor Function
Primary SF-36 QOL Survey
Primary Range of Motion
Primary Muscle Strength Test
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