Balance Recovery and Training on Fall Prevention in Stroke
Recruitment status was Not yet recruiting
|First Received Date ICMJE||June 30, 2005|
|Last Updated Date||September 13, 2005|
|Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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||Complete list of historical versions of study NCT00173992 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To investigate the incidence of falls before and after training|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Balance Recovery and Training on Fall Prevention in Stroke|
|Official Title ICMJE||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.
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||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Intervention ICMJE||Behavioral: Balance and Exercise|
|Study Arm (s)||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 Status ICMJE||Not yet recruiting|
|Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||45 Years to 75 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||Taiwan|
|NCT Number ICMJE||NCT00173992|
|Other Study ID Numbers ICMJE||9361701257|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Taiwan University Hospital|
|Collaborators ICMJE||National Health Research Institutes, Taiwan|
|Information Provided By||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