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Completed

NCT Number: NCT00995774

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Medical Center, DC

Washington D.C., District of Columbia, 20422, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic therapy

Device

12 sessions of robot therapy for arm and hand function

conventional functional training

Other

12 sessions of conventional therapy for the arm and hand from a physical therapist

Primary outcomes

  1. Fugl-Meyer Test of Motor Function

    Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2

    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.

Secondary outcomes

  1. Action Research Arm Test

    Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2

    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.

  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).

    Time frame: pre-treatment, post treatment

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 15, 2009
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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