Extension of the MIME Robotic System for Stroke Rehabilitation

Completed

Phase 2 Results

Trial Description

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

Interventions

  • Robotic therapy Device
    Intervention Desc: 12 sessions of robot therapy for arm and hand function
    ARM 1: Kind: Experimental
    Label: 1
    Description: robotic arm therapy
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: robotic arm therapy first, conventional therapy second
    ARM 3: Kind: Experimental
    Label: Arm 2
    Description: conventional therapy first, robotic therapy second
    ARM 4: Kind: Experimental
    Label: Robotic then Conventional
    Description: robotic arm therapy first, conventional therapy second
    ARM 5: Kind: Experimental
    Label: Conventional then Robotic
    Description: conventional therapy first, robotic therapy second
  • Conventional functional training Other
    Intervention Desc: 12 sessions of conventional therapy for the arm and hand from a physical therapist
    ARM 1: Kind: Experimental
    Label: 2
    Description: conventional therapy
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: robotic arm therapy first, conventional therapy second
    ARM 3: Kind: Experimental
    Label: Arm 2
    Description: conventional therapy first, robotic therapy second
    ARM 4: Kind: Experimental
    Label: Robotic then Conventional
    Description: robotic arm therapy first, conventional therapy second
    ARM 5: Kind: Experimental
    Label: Conventional then Robotic
    Description: conventional therapy first, robotic therapy second

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The Fugl-Meyer Motor Function test will be used to assess motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). pre-treatment, post treatment and 6-month followup No
Secondary The Jebsen-Taylor Test of Hand Function (Jebsen 1969) is a standardized assessment of the time it takes to perform hand activities. pre-treatment, post treatment and 6-month followup No
Secondary 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 and 6-month followup No
Secondary Action Research Arm test is a standardized assessment of functional limitations in the upper extremity. pre-treatment, post treatment No
Primary Fugl-Meyer Test of Motor Function before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 No
Secondary Action Research Arm Test before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 No

Sponsors