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

Sponsor

Kaohsiung Veterans General Hospital. (Other)

Overall Status

Completed

CT.gov ID

NCT01781689

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: Functional Electric Stimulation Other: Rehabilitation programs	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

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 :

Oct 1, 2012

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cortical activation [weekly changes within 3 months]
Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

Secondary Outcome Measures

motor function [weekly changes within 3 months]
assess motor function every week for 3 months

Other Outcome Measures

Activity of daily living function [weekly changes within 3 months]
assess Activity of daily living function weekly for 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	81362

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT01781689

Other Study ID Numbers:

VGHKS102-086
VGHKS12-CT7-07

First Posted:

Feb 1, 2013

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Keywords provided by Zheng-Yu Hoe, Principal Investigator, Kaohsiung Veterans General Hospital.

cortical activation

motor function

activity of daily living

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Feb 21, 2021