The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Zheng-Yu Hoe, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01781689
First received: January 27, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention
Stroke
Procedure: Functional Electric Stimulation
Other: Rehabilitation programs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Cortical activation [ Time Frame: weekly changes within 3 months ] [ Designated as safety issue: No ]
    Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months


Secondary Outcome Measures:
  • motor function [ Time Frame: weekly changes within 3 months ] [ Designated as safety issue: No ]
    assess motor function every week for 3 months


Other Outcome Measures:
  • Activity of daily living function [ Time Frame: weekly changes within 3 months ] [ Designated as safety issue: No ]
    assess Activity of daily living function weekly for 3 months


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
traditional rehabilitation program
Other: Rehabilitation programs
include occupational therapy and physical therapy
No Intervention: Health
with no motor function impairment

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
  • Vital sign stable
  • Upper extremity motor function impairment(brunnström stage I~III)

Exclusion Criteria:

  • with pacemakers
  • Seizure history
  • Serious dysrhythmias
  • Poor cognition function(MMSE<13)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781689

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Zheng-Yu Hoe Kaohsiung Veterans General Hospital.
  More Information

No publications provided

Responsible Party: Zheng-Yu Hoe, Principal Investigator, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01781689     History of Changes
Other Study ID Numbers: VGHKS102-086, VGHKS12-CT7-07
Study First Received: January 27, 2013
Last Updated: January 31, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
cortical activation
motor function
activity of daily living

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 31, 2014