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  Recruiting
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166907
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: June 2005
  Purpose

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 Intervention
Stroke
Behavioral: Balance and Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Balance Recovery and Training on Fall Prevention in Stroke

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject

Secondary Outcome Measures:
  • To investigate the incidence of falls before and after training

Estimated Enrollment: 100
Study Start Date: January 2002
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166907

Contacts
Contact: Pei-Fang Tang, PhD +886-2-23123456 ext 7557 pftang@ntu.edu.tw

Locations
Taiwan
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University 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 Unversity Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166907     History of Changes
Other Study ID Numbers: 9100005692
Study First Received: September 12, 2005
Last Updated: September 13, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Stroke
Balance
Proactive control
Reactive control
Recovery
Training
Fall

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014