Restless Legs Syndrome in Stroke Patients

Stroke Clinical Trial

Official title:

Restless Legs Syndrome in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967303
• Other study ID #: 3186
• Status: Completed
• Phase: N/A
• First received: September 15, 2013
• Last updated: October 17, 2013
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or older

• Hospitalization for stroke or transient ischemic attack

Exclusion Criteria:

• 18 years old or younger

• No stroke or transient ischemic attack

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Psychomotor Agitation
• Restless Legs Syndrome
• Stroke
• Syndrome
• Transient Ischemic Attack

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls.	The frequency (prevalence) of restless leg syndrome (RLS) in patients who have suffered stroke or TIA will be compared to that of subjects who have not suffered stroke or TIA (controls). The two groups will be stratified with regard to age and gender. Statistical comparison will be made by univariate analyses and by multivariate logistic regression analyses (which will include cerebrovascular risk factors besides stroke or TIA).	At time of interview	No