Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living

This study is currently recruiting participants.
Verified October 2010 by Medical College of Wisconsin
Sponsor:
Collaborators:
Marquette University
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00878085
First received: March 23, 2009
Last updated: October 20, 2010
Last verified: October 2010

March 23, 2009
October 20, 2010
November 2008
January 2013   (final data collection date for primary outcome measure)
  • Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor [ Time Frame: Pre (2x) , Post, Follow-Up ] [ Designated as safety issue: No ]
  • Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness [ Time Frame: Pre (2x), Post, Follow-up ] [ Designated as safety issue: No ]
  • Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index [ Time Frame: Pre (1x), Post, Follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00878085 on ClinicalTrials.gov Archive Site
  • Clinical Measures: Joint ROM, MMT, Spasticity [ Time Frame: Pre(2x), Post, Follow-up ] [ Designated as safety issue: No ]
  • Clinical Measures: Pain, Exertion [ Time Frame: During Therapy ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
fMRI and Robot-Assisted Practice of Activities of Daily Living

The investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity.The investigators hypothesize that robot training will lead to larger improvements as compared to standard occupational therapy. The investigators hypothesize that high responders to the robot training will have reduced compensatory activation in the bilateral area and will connectivity in the motor tracts.

Robot-assisted therapy is on the cutting edge of stroke rehabilitation and is a therapy method that promises to improve the lives of persons with disabilities due to stroke. Preliminary studies using these tools provide mixed evidence for their effectiveness and reveal limitations. For example, inconsistent carryover of motor gains to real life activities of daily living (ADLs) is seen. Therefore, it is still not clear what treatment strategies maximize functional outcomes on ADLs. There is a need to study the stroke recovery process and to understand how to optimize robot-assisted therapies in order to enhance patient rehabilitation and improve functional outcomes. Imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) can assist us in understanding the stroke recovery process, in determining who may benefit from robot-assisted training, and in defining how training induced functional cortical changes occur after robot training. We propose to conduct an interventional study plus control to assess the effectiveness of four weeks of robot-assisted practice of tasks with skilled functional tasks that involve reaching and grasping activities similar to real activities. We will examine the process of recovery for low-to-moderate functioning stroke survivors with chronic disability. We will assess the ability of active-assisted reaching and grasping training to effect immediate gains and long-term functional improvements. Further, using fMRI and DTI, we plan to associate changes seen in motor impairment levels and functional task performance levels with white matter injuries and connectivity and changes in oxygen utilization in the motor cortex as well as other areas of the brain. Our short-term aims are to, i) assess short-term functional gains after practice of skilled reaching and grasping tasks; ii) assess maintenance of these improvements; iii) quantify the neuronal changes associated with short-term gains, and iv) identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity. In the long-term, we hope to improve understanding of the process of ADL functional recovery after stroke and optimize robot-training strategies leading to cerebral plasticity. We also hope to determine how lesion characteristics affect changes seen in function, white matter connectivity, and cortical activity. By, accomplishing these aims, we hope to improve upper extremity function after stroke and reduce disability.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hemiparesis
  • Ischemic Stroke
  • Chronic
  • Device: Robot Therapy Device
    3x a week for 4 weeks
  • Behavioral: Occupational Therapy
    3x a week for 4 weeks
  • Experimental: 1
    Robot Therapy with activities of daily living (ADLs)
    Intervention: Device: Robot Therapy Device
  • Active Comparator: 2
    Standard Occupational Therapy
    Intervention: Behavioral: Occupational Therapy
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
61
June 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Stroke:

  • 30 to 85 years
  • Right-handed (evaluated with handedness survey)
  • suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
  • at least 6-months post-stroke
  • residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
  • not claustrophobic
  • not depressed (as measured depression survey)
  • able to use the scanner, i.e., passes the fMRI screening survey
  • able to understand the instructions and complete the tracking tasks Control
  • older than 20 years
  • Right-handed (evaluated with survey)
  • not claustrophobic
  • able to use the scanner, i.e., passes the fMRI screening survey
  • able to understand the instructions and complete the tracking tasks
  • no history of neurological disorders --not depressed (as measured depression survey)

Exclusion Criteria:

Stroke:

  • brain stem, stroke
  • pre-existing neurological or psychiatric disorders
  • Spasticity >3 at elbow or fingers on Ashworth
  • demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
  • shoulder pain or joint pain during movements
  • synkinetic movements or mirror movements
  • decline to participate
  • will not comply with full protocol
  • pregnant
  • allergic to goretex and conductivity gel

Control

  • decline to participate
  • will not comply with full protocol
  • pregnant
  • allergic to goretex and conductivity gel
Both
30 Years to 85 Years
Yes
Contact: Michelle J Johnson, PhD 414 384-2000 ext 45878 mjjohnso@mcw.edu
United States
 
NCT00878085
HR, NIH 1K25NS058577 - 01A1
Yes
Michelle J Johnson, PhD, Medical College of Wisconsin
Medical College of Wisconsin
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Department of Veterans Affairs
  • Marquette University
Study Chair: Michel Torbey, MD Medical College of Wisconsin
Medical College of Wisconsin
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP