Balance Recovery and Training on Fall Prevention in Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173992
First received: June 30, 2005
Last updated: September 13, 2005
Last verified: June 2005

June 30, 2005
September 13, 2005
September 2005
Not Provided
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
Same as current
Complete list of historical versions of study NCT00173992 on ClinicalTrials.gov Archive Site
To investigate the incidence of falls before and after training
Same as current
Not Provided
Not Provided
 
Balance Recovery and Training on Fall Prevention in Stroke
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Stroke
Behavioral: Balance and Exercise
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2007
Not Provided

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
Both
45 Years to 75 Years
Yes
Contact: Pei-Fang Tang, PhD +886-2-2312-3456 ext 7557 pftang@ntu.edu.tw
Taiwan
 
NCT00173992
9361701257
Not Provided
Not Provided
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Principal Investigator: Pei-Fang Tang, PhD National Taiwan University Hospital
National Taiwan University Hospital
June 2005

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