Balance Recovery and Training on Fall Prevention in Stroke

Stroke Clinical Trial

Official title:

Balance Recovery and Training on Fall Prevention in Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00173992
• Other study ID #: 9361701257
• Status: Not yet recruiting
• Phase: N/A
• First received: June 30, 2005
• Last updated: September 13, 2005
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: Pei-Fang Tang, PhD
• Phone: +886-2-2312-3456
• Email: pftang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Balance and Exercise

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
Secondary	To investigate the incidence of falls before and after training