StrokeNCT00166907
Balance Recovery and Training on Fall Prevention in Stroke
A study testing Balance and Exercise in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Balance and Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2002to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, 100
Pei-Fang Tang, PhD, +886-2-23123456 ext. 7557, pftang@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Balance and Exercise
- Keywords
- Stroke, Balance, Proactive control, Reactive control, Recovery, Training, Fall
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
Secondary outcomes (1)
To investigate the incidence of falls before and after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, National Taiwan Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166907
- Sponsor's protocol ID
- 9100005692
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 14 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Recovery and Training on Fall Prevention in Stroke
- ClinicalTrials.gov ID
- NCT00166907
- Acronym / sponsor ID
- 9100005692
- Conditions
- Stroke
- Keywords
- Stroke, Balance, Proactive control, Reactive control, Recovery, Training, Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jan 2002
- Study completion
- Dec 2007
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance and Exercise | Behavioural | – |
Primary outcome
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject
1 secondary outcome
To investigate the incidence of falls before and after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fang Tang, PhD principal investigator
National Taiwan Unversity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and Exercise in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Fang Tang, PhD (+886-2-23123456 ext. 7557, pftang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2005.