A Longitudinal Study of Function and Participation in Patients With Stroke

Stroke Clinical Trial

Official title:

A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02377453
• Other study ID #: 102-5783B
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2015
• Last updated: October 3, 2016
• Start date: April 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ling Chen, MD, PhD
• Phone: +886-3-3281200
• Email: clingchen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

Brain damage may lead to various motor deficits, which further influence the function and participation. Cerebral vascular accident (CVA) is the common disorder for acquired brain damage. Neural network in patients with brain damage could also be used to determine their clinical behavior by identifying altered neural network associated with behavioral improvement. The investigators hypothesize that the level of brain image and biomechanical will change with time in patients with stroke. Under this hypothesis, the measures of biomechanical change are correlated with neural changes. The aim of this study is to investigate the function and participation in patients with stroke evaluated by clinical measures, biomechanical, psychological, physiological and multimodal brain image. The primary goal of this study is to establish, evaluate and follow-up biomechanical- and image-based biomarkers for the impairment of function and participation information processing present in patients with stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with stroke

2. Aged 20-80 years old

3. Both ischemic stroke and hemorrhage

Exclusion Criteria:

1. Contraindication to MRI, such as metallic implant

2. History of psychiatric disease

3. Received Botulinum toxin (BTX-A) injection or surgery in recent six months

4. Severe psychological impairments, such as mental retardation or severe Communication problems

5. Progressive disorders, such as neurodegenerative disease

6. Active medical disease, such as infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months	fc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)	baseline, 6 months, 12 months	No
Secondary	Change from baseline of psychological in 6 months and 12 months	CANTAB touchscreen	baseline, 6 months, 12 months	No
Secondary	Change from baseline of body composition in 6 months and 12 months	InBody230 Body Composition Analyzer	baseline, 6 months, 12 months	No
Secondary	Change from baseline of severity in 6 months and 12 months	Brunnstrom stage classification, Modified Ashworth Scale and National Institute of Health Stroke Scale	baseline, 6 months, 12 months	No
Secondary	Change from baseline of body in 6 months and 12 months	Minimal Mental State Examination, Beck Depression Inventory-II, Fugl-Meyer assessment, Pediatric Berg Balance Scale, Action Research Arm Test and Box and Block Test	baseline, 6 months, 12 months	No
Secondary	Change from baseline of activity in 6 months and 12 months	Barthel Index, Wolf motor function test, Motor activity log, Walking test, Timed 'Up & Go' test and Functional Independence Measure	baseline, 6 months, 12 months	No
Secondary	Change from baseline of participation in 6 months and 12 months	Adaptive behavior assessment system and Nottingham Health Profile	baseline, 6 months, 12 months	No
Secondary	Change from baseline of quality of life in 6 months and 12 months	Stroke Impact Scale	baseline, 6 months, 12 months	No