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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Completed

CT.gov ID

NCT00878085

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH), US Department of Veterans Affairs (U.S. Fed), Marquette University (Other)

Enrollment

Locations

Arms

Duration (Months)

30.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hemiparesis Ischemic Stroke Chronic	Device: Robot Therapy Device Behavioral: Occupational Therapy	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

fMRI and Robot-Assisted Practice of Activities of Daily Living

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Clinical Measures: Joint ROM, MMT, Spasticity [Pre(2x), Post, Follow-up]
Clinical Measures: Pain, Exertion [During Therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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