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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Functional Electric Stimulation

Rehabilitation programs

About this trial

This is an interventional basic science trial for Stroke focused on measuring cortical activation, motor function, activity of daily living

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Functional Electric Stimulation

traditional rehabilitation program

Health

Arm Description

perform arm cranking with functional electrical stimulation

Receive traditional rehabilitation programs

with no motor function impairment

Outcomes

Primary Outcome Measures

Cortical activation

Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

Secondary Outcome Measures

motor function

assess motor function every week for 3 months

Full Information

NCT ID

NCT01781689

First Posted

January 27, 2013

Last Updated

October 2, 2023

Sponsor

Kaohsiung Veterans General Hospital.

1. Study Identification

Unique Protocol Identification Number

NCT01781689

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

cortical activation, motor function, activity of daily living

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Functional Electric Stimulation

Arm Type

Experimental

Arm Description

perform arm cranking with functional electrical stimulation

Arm Title

traditional rehabilitation program

Arm Type

Sham Comparator

Arm Description

Receive traditional rehabilitation programs

Arm Title

Health

Arm Type

No Intervention

Arm Description

with no motor function impairment

Intervention Type

Procedure

Intervention Name(s)

Functional Electric Stimulation

Intervention Description

apply to the hemiplegia affected limbs, helping movement

Intervention Type

Other

Intervention Name(s)

Rehabilitation programs

Intervention Description

include occupational therapy and physical therapy

Primary Outcome Measure Information:

Title

Cortical activation

Description

Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

Time Frame

weekly changes within 3 months

Secondary Outcome Measure Information:

Title

motor function

Description

assess motor function every week for 3 months

Time Frame

weekly changes within 3 months

Other Pre-specified Outcome Measures:

Title

Activity of daily living function

Description

assess Activity of daily living function weekly for 3 months

Time Frame

weekly changes within 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zheng-Yu Hoe

Organizational Affiliation

Kaohsiung Veterans General Hospital.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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