NCT02358252

Brief Summary

This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

6 years

First QC Date

January 28, 2015

Last Update Submit

January 29, 2020

Conditions

Cerebrovascular Accident

Keywords

Heart Rate Variabilityorthostatic hypotensionstrokeintegrated intelligent biosensor system

Outcome Measures

Primary Outcomes (1)

  • Change of Heart Rate Variability (HRV)

    measure subject's HRV, every 3 mins during the Tilt table test

    Baseline: before Tilt table test, resting position, measure HRV with 3 minutes interval, totally 7 HRVs were measured

Study Arms (2)

Orthostatic hypotension

Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV). Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension.

Non-orthostatic hypotension

Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV) Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension.

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

stroke patients

You may qualify if:

  • Patients who are first time to get stroke.

You may not qualify if:

  • unstable physiological conditions, serious joint spasticity, use cortisol or calming drugs, other neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

StrokeHypotension, Orthostatic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesHypotension

Study Officials

  • TaSen Wei

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 6, 2015

Study Start

January 1, 2014

Primary Completion

December 22, 2019

Study Completion

January 22, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

TW(1)