Extension of the MIME Robotic System for Stroke Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Impaired Upper Extremity Function
• Intervention / Treatment: Device: robotic therapy; Other: conventional functional training

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • VA Medical Center, DC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study;
• trace ability to move the wrist and fingers in extension;
• voluntary shoulder elevation to approximately 45 deg;
• be between the ages of 21 and 90.

Exclusion Criteria:

• Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988);
• have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols;
• have an upper extremity injury or conditions prior to stroke that could limit participation;
• have severe hemispatial neglect.
• have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and
• have severe sensory loss.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic then Conventional; robotic arm therapy first, conventional therapy second	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
EXPERIMENTAL: Conventional then Robotic; conventional therapy first, robotic therapy second	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Test of Motor Function	This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.	before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test	This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.	before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).		pre-treatment, post treatment

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Peter S. Lum, PhD, VA Medical Center, DC

Publications and helpful links

General Publications

• Brokaw EB, Nichols D, Holley RJ, Lum PS. Robotic therapy provides a stimulus for upper limb motor recovery after stroke that is complementary to and distinct from conventional therapy. Neurorehabil Neural Repair. 2014 May;28(4):367-76. doi: 10.1177/1545968313510974. Epub 2013 Dec 2.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (ESTIMATE): October 15, 2009

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: treatment; stroke; function; hand; robotic; therapy; motor; movement; arm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B4719-R