- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173992
Balance Recovery and Training on Fall Prevention in Stroke
The specific aims of this research are delineated as the following:
Aim 1: To investigate the neuromuscular and biomechanical mechanisms of the emerging processes of proactive and reactive balance control during sitting and standing in patients with stroke at different stages of the recovery course.
Aim 2: To determine the relationships between brain lesion sites and the recovery patterns of reactive and proactive balance control mechanisms in patients with stroke.
Aim 3: To determine the relationships between the impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke.
Aim 4: To investigate the efficacy of different training regimens in improving reactive and proactive balance control strategies and in preventing falls in stroke patients with different brain lesion sites.
Principally, three hypotheses are to be tested:
Hypothesis 1:The emerging processes and recovery patternes of proactive and reactive balance control may be different among stroke patients with different brain lesion locations.
Hypothesis 2:There are positive correlations between the level of impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke.
Hypothesis 3:Training regimens that could best facilitate the emergence or improvement in reactive and proactive balance control strategies are different.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pei-Fang Tang, PhD
- Phone Number: 7557 +886-2-2312-3456
- Email: pftang@ntu.edu.tw
Study Locations
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Taipei, Taiwan, 100
- School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
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Contact:
- Pei-Fang Tang, PhD
- Phone Number: 7557 +886-2-23123456
- Email: pftang@ntu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy subjects
- Age ang Sex are correspond with the stroke subjects(between 45 and 75 years old)
- having the habit of regular exercise (at least twice a week, and at least 20 minutes duration each time)
- being willing to accept one-year follow-up examination
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
Stroke subjects
- between 45 and 75 years old
- cerebral infarction stroke confirmed by ICD-10-CM and brain imaging diagnosis(including I63.0, I63.1, I63.2, I63.3, I63.4, I63.5, I63.6, I63.8, and I63.9)
- first stroke and received acute treatment at NTUH
- being willing to accept one-year follow-up examination
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
Exclusion Criteria:
Healthy subjects
- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability Stroke subjects
- on the 14st day after stroke onset, having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
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Secondary Outcome Measures
Outcome Measure |
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To investigate the incidence of falls before and after training
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pei-Fang Tang, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9361701257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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