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Factors Influencing Postural Balance and Movement in Individuals With Stroke (FIPBMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159792
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Vimonwan Hiengkaew, Mahidol University

Brief Summary:
There are several factors influencing on balance and movement in individuals with stroke, such as previous stroke, age, bowel incontinence, visuospatial problem. However, those factors involving in postural control and voluntary movement were studied in subacute and chronic phase of stroke, but not in the acute period. The aim of the study is to determine factors for postural control and voluntary movement in individuals with acute stroke and then follow at the first, third, and sixth month.

Condition or disease Intervention/treatment
Stroke Movement, Abnormal Postural, Balance Other: no intervention

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Study Type : Observational
Estimated Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Influencing on Postural Balance and Voluntary Movement in Individuals With Acute Stroke
Estimated Study Start Date : November 10, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : November 9, 2022

Group/Cohort Intervention/treatment
stroke
Those with standard treatment as usual.
Other: no intervention
No intervention




Primary Outcome Measures :
  1. National Institutes of Health Stroke Scale [ Time Frame: 6 months ]
    severity of stroke

  2. Postural Assessment Scale for Stroke [ Time Frame: 6 months ]
    postural balance

  3. Stroke Rehabilitation Assessment of Movement [ Time Frame: 6 months ]
    voluntary movement


Secondary Outcome Measures :
  1. subitem of Postural Assessment Scale for Stroke [ Time Frame: 6 months ]
    maintain and change posture

  2. subitem of Stroke Rehabilitation Assessment of Movement [ Time Frame: 6 months ]
    upper and lower limb movement and basic mobility



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with stroke.
Criteria

Inclusion Criteria:

  1. 18 years old and over
  2. First stroke

Exclusion Criteria:

  1. Recurrent stroke
  2. Having other neurological diseases such as brain tumor, Parkinson's Disease
  3. Systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg
  4. Having heart failure recorded in patient's file
  5. Having joint limitation in functional range
  6. Difficulty in communication (i.e. sensory aphasia, severe hearing loss)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159792


Locations
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Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Contact: Vimonwan Hiengkaew, PhD    +6624415450 ext 20801    vimonwan.hie@mahidol.ac.th   
Principal Investigator: Vimonwan Hiengkaew, PhD         
Sponsors and Collaborators
Vimonwan Hiengkaew
Investigators
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Principal Investigator: Vimonwan Hiengkaew, PhD Faculty of Physical Therapy, Mahidol University
Publications:
Ivanenko Y, Gurfinkel VS.Human Postural Control. Front Neurosci. 2018 Mar 20;12:171. doi: 10.3389/fnins.2018.00171.
Lesser M BJ, Dekerlegand J. Use of the postural assessment scale for stroke patients in determining acute care discharge recommendations. J Acute Care Phys Ther 2017:79-85.

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Responsible Party: Vimonwan Hiengkaew, Principle investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT04159792    
Other Study ID Numbers: 2019/199.3007
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vimonwan Hiengkaew, Mahidol University:
stroke
upper limb
lower limb
mobility
posture
Additional relevant MeSH terms:
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Stroke
Dyskinesias
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Movement Disorders
Neurologic Manifestations
Signs and Symptoms