Muscle Tone Changes in Acute Stroke According to Brain In... | NCT01041560

Studies
Muscle Tone Changes in Acute Stroke According to Brain Injury

NCT01041560

Sponsor

Jyväskylä Central Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Dec 30, 2009

First Submission Date that Met QC Criteria

Dec 30, 2009

First Posted Date

Dec 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2009

Last Update Posted Date

Dec 31, 2009Estimated

Name	Class
Eurostars	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to examine connections between muscle tones, strength and function after stroke.

Detailed Description

Measurements are intended to repeat every two days in acute phase to discover possible changes in tone and strength in arm and leg muscles.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stoke		Hemiplegia with unilateral changes in tone and muscle strength

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle tone		Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital

Secondary Outcomes

Measure	Description	Time Frame
Muscle strength		Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral decline in the arm or leg muscle strength

Exclusion Criteria:

unwilling to take part on the trial
not conscious
no differences between muscle strength on the right and left side

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Stroke patients in Middle-Finland Central hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jari Ylinen, MD, PhD	Contact	+358142691145		jari.ylinen@ksshp.fi

Overall Officials

Name	Affiliation	Role
Jari Ylinen, MD, PhD	Senior physician	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Finland Health Care District	Recruiting	Jyväskylä		40740	Finland

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided