Motor Learning of a Planning Task in Stroke Patients: the... | NCT00740402

Studies
Motor Learning of a Planning Task in Stroke Patients: the Maze Paradigm Measured Through Time and Error as Variables

NCT00740402

Sponsor

Faculdades Metropolitanas Unidas

Status

Completed

Last Update Posted

Apr 16, 2010Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Brazil

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

ID	Type	Description	Link
GPalma 123	Other Identifier	UNICID/USP

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Aug 22, 2008

First Submission Date that Met QC Criteria

Aug 22, 2008

First Posted Date

Aug 25, 2008Estimated

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

Apr 15, 2010

Last Update Posted Date

Apr 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects.

Detailed Description

20 post-stroke patients were comprised to the experimental group (EG) and 20 health subjects were included to the control group (CG. Inclusion criteria: chronic stroke, single stroke event, lesion in anterior circulation, right handed subjects, MEEM over 23 points. The task consisted in a maze paradigm, made by pencil and paper, with the non affected side for EG and left upper extremity for CG. The instruction was given to the subjects to complete the task as fast as possible. The study consisted in three phases: acquisition (AQ)with 30 trials, transfer (TR, short retention (R1)and long term retention (R2 both with 5 trials.

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

Retention

Enrollment

20Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TIME	time (in seconds)	3 times in a week (acquisition, transfer an retention phase)

Secondary Outcomes

Measure	Description	Time Frame
error	number of mistakes made by the subjects	3 times in a week (acquisition, transfer an retention phase)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 40 and 65
Injury in territory of movement earlier, as shown by examination of image and finding medical neurologist
Time of injury over 6 months
Single vascular event
Right handed, by applying the Inventory of Dominance Side of Edinburgh Mini mental with scores over 23 points

Exclusion Criteria:

Aphasia of understanding
Instability clinic
Other neurological diseases associated (Parkinson's disease, dementias, Alzheimer)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients after stroke

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camila Torriani, doctor	University of Sao Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Center of Metropolitan United		São Paulo	São Paulo		Brazil

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