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

NCT ID: NCT01781689

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2019-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Functional Electric Stimulation

perform arm cranking with functional electrical stimulation

Group Type EXPERIMENTAL

Functional Electric Stimulation

Intervention Type PROCEDURE

apply to the hemiplegia affected limbs, helping movement

traditional rehabilitation program

Receive traditional rehabilitation programs

Group Type SHAM_COMPARATOR

Rehabilitation programs

Intervention Type OTHER

include occupational therapy and physical therapy

Health

with no motor function impairment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Functional Electric Stimulation

apply to the hemiplegia affected limbs, helping movement

Intervention Type PROCEDURE

Rehabilitation programs

include occupational therapy and physical therapy

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Zheng-Yu Hoe, MD., PhD.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zheng-Yu Hoe

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGHKS12-CT7-07

Identifier Type: OTHER

Identifier Source: secondary_id

VGHKS102-086

Identifier Type: -

Identifier Source: org_study_id

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