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Balance Recovery and Training on Fall Prevention in Stroke

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ClinicalTrials.gov Identifier: NCT00166907
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date September 14, 2005
Study Start Date  ICMJE January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To investigate the incidence of falls before and after training
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Balance Recovery and Training on Fall Prevention in Stroke
Official Title  ICMJE Balance Recovery and Training on Fall Prevention in Stroke
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: Balance and Exercise
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy adults

  • between 45 and 75 years old
  • having no neuromuscular or musculoskeletal disorders that would jeopardize their balance control abilities
  • being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Stroke patients

  • between 45 and 75 years old
  • hemiplegic or hemiparetic as a result of a single cerebral vascular accident with brain lesions primarily involving one of the following areas: the primary motor cortex, supplementary motor/premotor areas, parietal cortex, or basal ganglia
  • medically stable with no ongoing complications
  • within 30 days post stroke able to independently sit without using any assistive device for at least 3 minutes if being tested on the 14th and 30th days post-stroke and able to stand and take a fast step independently in standing without using any assistive device for at least 3 minutes when tested on the 60th, 90th, 180th, 360th, 540th, and 720th days post stroke onset
  • able to communicate with the experimenters
  • having no hemianopsia or any obvious cognitive problems as evaluated with the Mini-Mental State examination
  • being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Exclusion Criteria:

  • having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00166907
Other Study ID Numbers  ICMJE 9100005692
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Health Research Institutes, Taiwan
Investigators  ICMJE
Principal Investigator: Pei-Fang Tang, PhD National Taiwan Unversity Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP