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

This study has been completed.
Sponsor:
Collaborators:
Marquette University
Information provided by (Responsible Party):
Michelle J. Johnson, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00878085
First received: March 23, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hemiparesis
Ischemic Stroke
Chronic
Device: Robot Therapy Device
Behavioral: Occupational Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI and Robot-Assisted Practice of Activities of Daily Living

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 61
Study Start Date: November 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Robot Therapy with activities of daily living (ADLs)
Device: Robot Therapy Device
3x a week for 4 weeks
Active Comparator: 2
Standard Occupational Therapy
Behavioral: Occupational Therapy
3x a week for 4 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00878085

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Clement J Zablocki VA
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Medical College of Wisconsin
Marquette University
Investigators
Study Chair: Michel Torbey, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Michelle J. Johnson, Adjunct Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00878085     History of Changes
Other Study ID Numbers: HR, NIH 1K25NS058577 - 01A1
Study First Received: March 23, 2009
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Robot Therapy
Upper Limb
Stroke
Rehabilitation
fMRI
DTI

ClinicalTrials.gov processed this record on October 19, 2014