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

Ischemic Stroke Clinical Trial

Official title:

fMRI and Robot-Assisted Practice of Activities of Daily Living

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878085
• Other study ID #: HR
• Secondary ID: NIH 1K25NS058577
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2009
• Last updated: February 3, 2014
• Start date: November 2008
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic
• Hemiparesis
• Ischemic Stroke

Intervention

Device:
• Robot Therapy Device
3x a week for 4 weeks

Behavioral:
• Occupational Therapy
3x a week for 4 weeks

Locations

Country	Name	City	State
United States	Clement J Zablocki VA	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Marquette University, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor		Pre (2x) , Post, Follow-Up	No
Primary	Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness		Pre (2x), Post, Follow-up	No
Primary	Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index		Pre (1x), Post, Follow-up	No
Secondary	Clinical Measures: Joint ROM, MMT, Spasticity		Pre(2x), Post, Follow-up	No
Secondary	Clinical Measures: Pain, Exertion		During Therapy	Yes