The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients
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|ClinicalTrials.gov Identifier: NCT01781689|
Recruitment Status : Unknown
Verified March 2015 by Zheng-Yu Hoe, Kaohsiung Veterans General Hospital..
Recruitment status was: Enrolling by invitation
First Posted : February 1, 2013
Last Update Posted : April 1, 2015
Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.
Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).
This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: Functional Electric Stimulation Other: Rehabilitation programs||Not Applicable|
Participants receive evaluations (1/week for 3 months period) of
- motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
- cortical perfusion detection during performing limb movements (using NIRS)
Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||July 2016|
Experimental: Functional Electric Stimulation
perform arm cranking with functional electrical stimulation
Procedure: Functional Electric Stimulation
apply to the hemiplegia affected limbs, helping movement
Sham Comparator: traditional rehabilitation program
Receive traditional rehabilitation programs
Other: Rehabilitation programs
include occupational therapy and physical therapy
No Intervention: Health
with no motor function impairment
- Cortical activation [ Time Frame: weekly changes within 3 months ]Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months
- motor function [ Time Frame: weekly changes within 3 months ]assess motor function every week for 3 months
- Activity of daily living function [ Time Frame: weekly changes within 3 months ]assess Activity of daily living function weekly for 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781689
|Kaohsiung Veterans General Hospital|
|Kaohsiung, Taiwan, 81362|
|Principal Investigator:||Zheng-Yu Hoe||Kaohsiung Veterans General Hospital.|