NCT00407628

Brief Summary

To investigate the relationship between the integrity of the white matter, including the corticospinal tracts and the corpus callosum, with the recovery of lower extremity function in patients with cerebral stroke at the subacute and chronic stages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

December 3, 2006

Last Update Submit

July 4, 2013

Conditions

Stroke

Keywords

StrokeDiffusion spectrum tractographyFunctional MRI (fMRI)Lower extremity

Outcome Measures

Primary Outcomes (1)

  • clinical assessments, included balance, motor, walking,ADL, will be obtained for tests performed on D7, D30 and D90

    D30, D90 and D180 post stroke onset

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stroke patients

You may qualify if:

  • between 30 to 80 years old
  • diagnosis of the first-time onset of stroke as confirmed by imaging studies
  • within 30 days post onset University Hospital
  • brain lesions mainly involving either the cortical primary motor cortex (M1) area or confined to the subcortical (M1 spared)
  • No neurological or orthopedic problems which would affect their lower extremity function
  • no contraindications for MRI studies

You may not qualify if:

  • medically unstable
  • unable to communicate with the experimenters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

Taipei, Taiwan, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pei-Fang Tang, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2006

First Posted

December 5, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

July 8, 2013

Record last verified: 2013-01

Locations

CN(1)