Clinical trial NCT02377453: A Longitudinal Study of Function and Participation in Patients With Stroke
Official title: A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
participation
brain imaging
biomechanical
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimental groups

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of psychological in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of body composition in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of severity in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of body in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of activity in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of participation in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline of quality of life in 6 months and 12 months
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References: