Extension of the MIME Robotic System for Stroke Rehabilitation

NCT00995774 | Completed Phase 2 Results

• 1 other identifier: B4719-R
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Impaired Upper Extremity Function

Keywords

stroke; function; arm; hand; robotic; therapy; motor; movement; treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Action Research Arm Test

  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

Study Arms (2)

Robotic then Conventional

EXPERIMENTAL

robotic arm therapy first, conventional therapy second

Device: robotic therapy; Other: conventional functional training

Conventional then Robotic

EXPERIMENTAL

conventional therapy first, robotic therapy second

Device: robotic therapy; Other: conventional functional training

Interventions

robotic therapy DEVICE

12 sessions of robot therapy for arm and hand function

Robotic then Conventional

conventional functional training OTHER

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

Robotic then Conventional

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, DC

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

Location

Related Publications (1)

• 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.

  PMID: 24297763 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The limited therapy hours could mask potential gains that would have been made with additional therapy. Due to the small sample size, these results need to be confirmed in a larger scale study using a parallel study design.

Results Point of Contact

• Title: Peter Lum, PhD
• Organization: Washington DC Veterans Affairs Medical Center

lum@cua.edu

202-319-5181

Study Officials

• Peter S. Lum, PhD

  VA Medical Center, DC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 15, 2009
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 20, 2018
• Results First Posted: February 14, 2014

Record last verified: 2018-08

Locations

US (1)