NCT01632410

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

4 months

First QC Date

June 20, 2012

Last Update Submit

July 2, 2012

Conditions

Keywords

autonomic nerve systempost strokefocus of study: to describe the autonomic nerve system function post strokeautonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • RMSSD change

    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

    3 month post stroke

Secondary Outcomes (2)

  • 6mwt

    3 month post stroke

  • Patient's characteristics

    3 month post stroke

Study Arms (5)

Study group 1

Post hemispheral ischemic stroke cognitively intact. Exclusion: Subjects with severe visual or hearing impairments, stroke location brain steam. The group will be divided in to 4 goups acording to stroke specific location as demonstrated in MRI.

Control

Control: Healthy subjects resemble in age and sex

Study -3

As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.

Stydy -2

As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.

Stydy- 4

As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post hemispheral ischemic stroke cognitively intact.

You may qualify if:

  • Post hemispheral ischemic stroke cognitively intact.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Souraski Medical Center Neurology department

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nathan Borshtin, Prof.

    Tel Aviv Suraski medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natan Borshtain, prof.

CONTACT

Noa Raphaely Beer, Mrs.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

July 3, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2013

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations