NCT02377453

Brief Summary

A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 5, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

February 25, 2015

Last Update Submit

October 3, 2016

Conditions

Keywords

strokeparticipationbrain imagingbiomechanical

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months

    Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis

    baseline, 6 months, 12 months

Secondary Outcomes (8)

  • Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of psychological in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of body composition in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of severity in 6 months and 12 months

    baseline, 6 months, 12 months

  • Change from baseline of body in 6 months and 12 months

    baseline, 6 months, 12 months

  • +3 more secondary outcomes

Study Arms (2)

Control

Control: Healthy adult

Experimental

Experimental: patients with stroke

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Control and experimental groups

You may qualify if:

  • Patients with stroke
  • Aged 20-80 years old
  • Both ischemic stroke and hemorrhage

You may not qualify if:

  • Contraindication to MRI, such as metallic implant
  • History of psychiatric disease
  • Received Botulinum toxin (BTX-A) injection or surgery in recent six months
  • Severe psychological impairments, such as mental retardation or severe Communication problems
  • Progressive disorders, such as neurodegenerative disease
  • Active medical disease, such as infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chia-Ling Chen, MD, PhD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 3, 2015

Study Start

April 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

October 5, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations