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OpenTrials
Completed

NCT Number: NCT01781689

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional Electric Stimulation

Procedure

apply to the hemiplegia affected limbs, helping movement

Rehabilitation programs

Other

include occupational therapy and physical therapy

Primary outcomes

  1. Cortical activation

    Time frame: weekly changes within 3 months

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

Secondary outcomes

  1. motor function

    Time frame: weekly changes within 3 months

    assess motor function every week for 3 months

Other outcomes

  1. Activity of daily living function

    Time frame: weekly changes within 3 months

    assess Activity of daily living function weekly for 3 months

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2013
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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