The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study

• Conditions: Stroke

• Registration Number: NCT01632410
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The study describes the autonomic control system function in subjects post stroke in comparison with healthy subjects.

Aims: To describe the Autonomic hart rate control system function in post stroke subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the reflective reaction of the autonomic control system as reflected in the heart rate variability to stimulations subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the autonomic control system reaction as reflected in the heart rate variability to physical and cognitive action subjects in different rehabilitation levels in comparison with healthy subjects.

Detailed Description

Subjects will be examined 3 times: a week 1 and 3 month post stroke. Control consist similar in description healthy subjects, will be examined once. Each test includes 24 hours Holter surveillance and an examine that include general check that reflects the autonomic reaction to different manipulation.

The examination description:

A. Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.

B. Subjects will receive an examination that includes

* General neurological examination (strength, deep and superficial sensation, cognitive test and pain level.) C. Holter will be place for 24 hours. And autonomic examination test will be conducted

* Grip Test: emphases the sympathetic system.

* Breathing Test: emphases the parasympathetic system. D. Manipulation to examine the two sub systems. Each manipulation lasts1 minute.

Study Timeline

• Status Verified: 2012-06
• Study First Submitted: 2012-06-20
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-02
• Last Update Submitted: 2012-07-02
• Study First Posted: 2012-07-03
• Last Update Posted: 2012-07-03
• Primary Completion: 2012-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria

• Subjects with severe visual or hearing impairments, stroke location brain steam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RMSSD change	3 month post stroke	The root mean square successive difference (RMSSD) in heart period series is a time domain measure of heart period variability.; we will follow up the change in RMSSD at 1st and 3rd month post stroke

Secondary Outcome Measures

Name	Time	Method
6mwt	3 month post stroke	Endurance will be measured with the 6 minute walk test (6MWT). we will follow up the endurane change.
Patient's characteristics	3 month post stroke	a. Patient's characteristics questionnaire will include data such as: age, gender, health condition, medication, habits, education, etc.; B. mRS and NIHSS questionears

Trial Locations

Locations (1)

Tel Aviv Souraski Medical Center Neurology department; 🇮🇱 Tel Aviv, Israel