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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: Functional Electric Stimulation; Other: Rehabilitation programs

• Registration Number: NCT01781689
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Electric Stimulation	Functional Electric Stimulation	perform arm cranking with functional electrical stimulation
traditional rehabilitation program	Rehabilitation programs	Receive traditional rehabilitation programs

Primary Outcome Measures

Name	Time	Method
Cortical activation	weekly changes within 3 months	Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

Secondary Outcome Measures

Name	Time	Method
motor function	weekly changes within 3 months	assess motor function every week for 3 months

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan