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Extension of the MIME Robotic System for Stroke Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00995774
First received: October 8, 2009
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

The goal of this project is to further develop the MIME system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME 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.


Condition Intervention Phase
Stroke
Impaired Upper Extremity Function
 Device: robotic therapy
Other: conventional functional training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension of the MIME Robotic System for Stroke Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Fugl-Meyer Motor Function test will be used to assess motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). [ Time Frame: pre-treatment, post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Action Research Arm test is a standardized assessment of functional limitations in the upper extremity. [ Time Frame: pre-treatment, post treatment ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: pre-treatment, post treatment ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
robotic arm therapy first, conventional therapy second
 Device: robotic therapy
12 sessions of robot therapy for arm and hand function using the MIME system
Other: conventional functional training
12 sessions of conventional therapy for the arm and hand from a physical therapist
Experimental: Arm 2
conventional therapy first, robotic therapy second
 Device: robotic therapy
12 sessions of robot therapy for arm and hand function using the MIME system
Other: conventional functional training
12 sessions of conventional therapy for the arm and hand from a physical therapist

Detailed Description:

Research Design:

We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after MIME training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after MIME training will be greater than after dose-matched conventional therapy; 3) Unlike in previous studies, gains in both proximal arm and hand function at the 6-month followup will be greater after MIME training than after dose-matched conventional therapy.

Methodology:

In the first year of the study, we will extend the current MIME 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 current MIME system so that tasks such as arm reach, grasp of an object and release of the object can be trained. All of the training modes currently available for reaching movements will be extended to hand function. In the last 2 years of the project, we will perform a pilot clinical trial with 30 subjects comparing this new training paradigm to dose-matched conventional therapy in subacute and chronic stroke survivors. Outcome measures will be taken before training, immediately after training.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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);
  2. have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols;
  3. have an upper extremity injury or conditions prior to stroke that could limit participation;
  4. have severes hemispatial neglect.
  5. have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and
  6. have severe sensory loss.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995774

Locations
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Peter S. Lum, PhD VA Medical Center, DC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00995774     History of Changes
Other Study ID Numbers: B4719-R
Study First Received: October 8, 2009
Last Updated: September 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
stroke
function
arm
hand
robotic
 therapy
motor
movement
treatment

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013