Balance Recovery and Training on Fall Prevention in Stroke

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: Balance and Exercise	Not Applicable

Detailed Description:

Stroke is one of the leading causes of chronic disability in the world. Falls are one of the primary complications after stroke. The incidence of falls ranges from 25% to 75% among stroke patients residing in different settings, with greater incidence of falls occurring after discharge home. Postural instability has been suggested as one of the main causes leading to falls in this population. The recovery of the ability to maintain balance during activities of daily living, therefore, is essential for functional independence and safety of these patients. In the following paragraphs, the knowledge gaps taht we are proposing to bridge in this study and the revelant literature that leads us to identify these gaps are discussed.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	100 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Educational/Counseling/Training
Official Title:	Balance Recovery and Training on Fall Prevention in Stroke
Study Start Date :	September 2005
Study Completion Date :	December 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject

Secondary Outcome Measures :

1. To investigate the incidence of falls before and after training

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Contacts

Contact: Pei-Fang Tang, PhD	+886-2-2312-3456 ext 7557	pftang@ntu.edu.tw

Locations

Taiwan
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University	Not yet recruiting
Taipei, Taiwan, 100
Contact: Pei-Fang Tang, PhD +886-2-23123456 ext 7557 pftang@ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

National Health Research Institutes, Taiwan

Investigators

Principal Investigator:	Pei-Fang Tang, PhD	National Taiwan University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00173992 History of Changes
Other Study ID Numbers:	9361701257
First Posted:	September 15, 2005
Last Update Posted:	September 15, 2005
Last Verified:	June 2005

Keywords provided by National Taiwan University Hospital:

Stroke; Balance; Proactive control; Reactive control	Recovery; Training; Fall

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases