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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Hemiparesis; Chronic
• Intervention / Treatment: Device: Robot Therapy Device; Behavioral: Occupational Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Clement J Zablocki VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor	Pre (2x) , Post, Follow-Up
Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness	Pre (2x), Post, Follow-up
Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index	Pre (1x), Post, Follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Measures: Joint ROM, MMT, Spasticity	Pre(2x), Post, Follow-up
Clinical Measures: Pain, Exertion	During Therapy

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); US Department of Veterans Affairs; Marquette University
• Investigators: Study Chair: Michel Torbey, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: April 7, 2009
• First Posted (Estimate): April 8, 2009

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; fMRI; DTI; Upper Limb; Robot Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Ischemic Stroke; Paresis
• Other Study ID Numbers: HR; NIH 1K25NS058577 - 01A1