StrokeNCT02377453
A Longitudinal Study of Function and Participation in Patients With Stroke
An observational study of Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control and experimental groups
Who may be able to join
- Patients with stroke
- Aged 20-80 years old
- Both ischemic stroke and hemorrhage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 333
Chia-Ling Chen, MD, PhD, +886-3-3281200 ext. 8147, clingchen@gmail.com
Chia-Ling Chen, MD, PhD
About this study
Official title: A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
A longitudinal study of function and participation in patients with stroke: An integrated brain imaging and biomechanical analysis
Read the 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.
- Conditions
- Stroke
- Keywords
- stroke, participation, brain imaging, biomechanical
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Control: Healthy adult | |
| Experimental | Experimental: patients with stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months, 12 months
Secondary outcomes (8)
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)
Measured: baseline, 6 months, 12 months
Change from baseline of psychological in 6 months and 12 months
CANTAB touchscreen
Measured: baseline, 6 months, 12 months
Change from baseline of body composition in 6 months and 12 months
InBody230 Body Composition Analyzer
Measured: baseline, 6 months, 12 months
Change from baseline of severity in 6 months and 12 months
Brunnstrom stage classification, Modified Ashworth Scale and National Institute of Health Stroke Scale
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
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
Measured: baseline, 6 months, 12 months
Change from baseline of participation in 6 months and 12 months
Adaptive behavior assessment system and Nottingham Health Profile
Measured: baseline, 6 months, 12 months
Change from baseline of quality of life in 6 months and 12 months
Stroke Impact Scale
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377453
- Sponsor's protocol ID
- 102-5783B
- Status last verified
- Sep 2016
- First submitted
- 25 Feb 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Function and Participation in Patients With Stroke: An Integrated Brain Imaging and Biomechanical Analysis
- ClinicalTrials.gov ID
- NCT02377453
- Acronym / sponsor ID
- 102-5783B
- Conditions
- Stroke
- Keywords
- stroke, participation, brain imaging, biomechanical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Control: Healthy adult |
| Experimental | – | –Experimental: patients with stroke |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control and experimental groups
Key inclusion criteria (3 listed)
- Patients with stroke
- Aged 20-80 years old
- Both ischemic stroke and hemorrhage
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Muscle tone, Muscle strength and Kinematic analysis for upper limb and gait analysis
8 secondary outcomes
Change from baseline of functional magnetic resonance imaging (fMRI) analysis in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of psychological in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of body composition in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of severity in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of body in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of activity in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of participation in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Change from baseline of quality of life in 6 months and 12 months
Time frame: baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, MD, PhD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ling Chen, MD, PhD (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of biomechanical measurement for Healthy adult and patients with stroke in 6 months and 12 months (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.