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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781689
• Other study ID #: VGHKS102-086
• Secondary ID: VGHKS12-CT7-07
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Functional Electric Stimulation
apply to the hemiplegia affected limbs, helping movement

Other:
• Rehabilitation programs
include occupational therapy and physical therapy

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity of daily living function	assess Activity of daily living function weekly for 3 months	weekly changes within 3 months
Primary	Cortical activation	Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months	weekly changes within 3 months
Secondary	motor function	assess motor function every week for 3 months	weekly changes within 3 months