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

October 2, 2023 updated by: Zheng-Yu Hoe, MD., PhD., Kaohsiung Veterans General Hospital.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical activation
Time Frame: weekly changes within 3 months
Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months
weekly changes within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
motor function
Time Frame: weekly changes within 3 months
assess motor function every week for 3 months
weekly changes within 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of daily living function
Time Frame: weekly changes within 3 months
assess Activity of daily living function weekly for 3 months
weekly changes within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Zheng-Yu Hoe, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

January 27, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimated)

February 1, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS102-086
  • VGHKS12-CT7-07 (Other Identifier: Kaohsiung V.G.H. Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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