NCT00995774

Extension of the MIME Robotic System for Stroke Rehabilitation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.

Detailed description

Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy. Methodology: In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.

Conditions

• Stroke
• Impaired Upper Extremity Function

Interventions

Type	Name	Description
DEVICE	robotic therapy	12 sessions of robot therapy for arm and hand function
OTHER	conventional functional training	12 sessions of conventional therapy for the arm and hand from a physical therapist
DEVICE	robotic therapy	12 sessions of robot therapy for arm and hand function
OTHER	conventional functional training	12 sessions of conventional therapy for the arm and hand from a physical therapist

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-10-15
• Last updated: 2018-09-20
• Results posted: 2014-02-14

Locations

1 site across 1 country: United States