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A Longitudinal Study of Function and Participation in Patients With Stroke

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02377453
Enrollment
300
Registered
2015-03-03
Start date
2014-04-30
Completion date
2017-03-31
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, participation, brain imaging, biomechanical

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.

Interventions

None listed

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 monthsbaseline, 6 months, 12 monthsMuscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis

Secondary

MeasureTime frameDescription
Change from baseline of activity in 6 months and 12 monthsbaseline, 6 months, 12 monthsBarthel Index, Wolf motor function test, Motor activity log, Walking test, Timed 'Up & Go' test and Functional Independence Measure
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 monthsbaseline, 6 months, 12 monthsfc(functional connectivity)MRI at resting, active-task fMRI. diffusion tensor imaging (DTI)
Change from baseline of psychological in 6 months and 12 monthsbaseline, 6 months, 12 monthsCANTAB touchscreen
Change from baseline of quality of life in 6 months and 12 monthsbaseline, 6 months, 12 monthsStroke Impact Scale
Change from baseline of severity in 6 months and 12 monthsbaseline, 6 months, 12 monthsBrunnstrom stage classification, Modified Ashworth Scale and National Institute of Health Stroke Scale
Change from baseline of body in 6 months and 12 monthsbaseline, 6 months, 12 monthsMinimal Mental State Examination, Beck Depression Inventory-II, Fugl-Meyer assessment, Pediatric Berg Balance Scale, Action Research Arm Test and Box and Block Test
Change from baseline of participation in 6 months and 12 monthsbaseline, 6 months, 12 monthsAdaptive behavior assessment system and Nottingham Health Profile
Change from baseline of body composition in 6 months and 12 monthsbaseline, 6 months, 12 monthsInBody230 Body Composition Analyzer

Countries

Taiwan

Contacts

Primary ContactChia-Ling Chen, MD, PhD
clingchen@gmail.com+886-3-3281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026