Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00878085
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2009-03-23
Brief Title:
Functional Magnetic Resonance Imaging fMRI and Robot-Assisted Practice of Activities of Daily Living
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
fMRI and Robot-Assisted Practice of Activities of Daily Living
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 connectivityThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH 1K25NS058577 - 01A1 | None | None | None |