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Extension of the MIME Robotic System for Stroke Rehabilitation

Primary Purpose

Stroke, Impaired Upper Extremity Function

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
robotic therapy
conventional functional training
robotic therapy
conventional functional training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, function, arm, hand, robotic, therapy, motor, movement, treatment

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical Center, DC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Robotic then Conventional

Conventional then Robotic

Arm Description

robotic arm therapy first, conventional therapy second

conventional therapy first, robotic therapy second

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
October 8, 2009
Last Updated
August 22, 2018
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00995774
Brief Title
Extension of the MIME Robotic System for Stroke Rehabilitation
Official Title
Extension of the MIME Robotic System for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Impaired Upper Extremity Function
Keywords
stroke, function, arm, hand, robotic, therapy, motor, movement, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic then Conventional
Arm Type
Experimental
Arm Description
robotic arm therapy first, conventional therapy second
Arm Title
Conventional then Robotic
Arm Type
Experimental
Arm Description
conventional therapy first, robotic therapy second
Intervention Type
Device
Intervention Name(s)
robotic therapy
Intervention Description
12 sessions of robot therapy for arm and hand function
Intervention Type
Other
Intervention Name(s)
conventional functional training
Intervention Description
12 sessions of conventional therapy for the arm and hand from a physical therapist
Intervention Type
Device
Intervention Name(s)
robotic therapy
Intervention Description
12 sessions of robot therapy for arm and hand function
Intervention Type
Other
Intervention Name(s)
conventional functional training
Intervention Description
12 sessions of conventional therapy for the arm and hand from a physical therapist
Primary Outcome Measure Information:
Title
Fugl-Meyer Test of Motor Function
Description
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.
Time Frame
before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
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.
Time Frame
before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S. Lum, PhD
Organizational Affiliation
VA Medical Center, DC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24297763
Citation
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.
Results Reference
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Extension of the MIME Robotic System for Stroke Rehabilitation

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