Wearable Robotic Functional Assistance for Stroke Rehabilitation

Myomo

Status: Completed

Conditions: CVA (Cerebrovascular Accident)

Treatments: Device: myomo e100 neurorobotic elbow brace

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396708

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)