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Balance Recovery and Training on Fall Prevention in Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Balance and Exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Stroke focused on measuring Stroke, Balance, Proactive control, Reactive control, Recovery, Training, Fall

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan UniversityRecruiting

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
September 13, 2005
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00166907
Brief Title
Balance Recovery and Training on Fall Prevention in Stroke
Official Title
Balance Recovery and Training on Fall Prevention in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Balance, Proactive control, Reactive control, Recovery, Training, Fall

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Balance and Exercise
Primary Outcome Measure Information:
Title
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
Secondary Outcome Measure Information:
Title
To investigate the incidence of falls before and after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Fang Tang, PhD
Phone
+886-2-23123456
Ext
7557
Email
pftang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Fang Tang, PhD
Organizational Affiliation
National Taiwan Unversity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Fang Tang, PhD
Phone
+886-2-23123456
Ext
7557
Email
pftang@ntu.edu.tw

12. IPD Sharing Statement

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Balance Recovery and Training on Fall Prevention in Stroke

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