AgingNCT02706496
Age-related Changes in Posture Control and Cortex Activity Under a Dynamic Perturbation
An observational study of Aging, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
With aging, the elderly decreased ability to control postural balance will be accompanied by increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it increased with age (Skelton, \& Todd… Read more about this study
- Who is it for?
- Ages 20 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2015to Jan 2016
- Phase
- Observational
- 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 20 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The volunteers from the community will be recruited in this study, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study.
Who may be able to join
- able to walk and climb the stairs without assistive devices,
- could follow the instructions, and
- without well-known balance related diseases or impairments.
Who cannot join
- With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study.
Trial locations and contacts
1 site in 1 country.
About this study
With aging, the elderly decreased ability to control postural balance will be accompanied by increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it increased with age (Skelton, \& Todd, 2004). In view of this, age-related posture control has become important issues of modern preventive medicine and family care.
Read the detailed description
Many clinical studies have been developed assessment tools and measurements for clinical staff to provide balanced assessment and intervention. However, the factors of affecting postural control are diverse and complex, not all tools or measurement could effectively detect a risk of falling. In daily living, the postural control involved integration of sensation, biofeedback, movement response, and kinesthetic sense to maintain postural stability, and finally integrated into the neuromuscular system and coordination to help achieve the perfect postural control. Current clinical tools used to assess the fall or research methods to detect the incidence of falls and the lack of effective relevant and contradictory, and it's difficult to effectively evaluate the risk of falls (Gates, et al, 2008).
With the development of postural balance issues associated with aging process in older people, there is no set of standardized equipment, and lack of effective methods for the assessment of normal and older people who fall. In response to these problems, if we can provide a virtual reality interfaces, and with daily living activities as gait, across obstacles activity, sit to stand, will be able to better meet the desire to explore the issue of real significance to enhance researchers for aging, motion analysis, and brain cortex activity mechanism in postural control mechanism.
- Conditions
- Aging
- Keywords
- aging of elderly, falling prevention, electroencephalography, postural control, biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young adults (20-35yr) | The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. | |
| middle age(45-60yr) | The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. | |
| elderly(65-74yr) | The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
center of pressure
0.5m pressure mat (RSscan, Inc., Belgium)
Measured: 3 minutes for 20 trial
Secondary outcomes (1)
cortex power spectrum density
32-channel Ag/AgCl Quick-Cap and NuAmps digital amplifier (Neuroscan, El Paso, TX, USA)
Measured: 3 minutes for 20 trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Tsui-Fen Yang, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706496
- Sponsor's protocol ID
- 2014-01-003C
- Status last verified
- Mar 2016
- First submitted
- 25 Aug 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mierau A, Hulsdunker T, Struder HK. Changes in cortical activity associated with adaptive behavior during repeated balance perturbation of unpredictable timing. Front Behav Neurosci. 2015 Oct 14;9:272. doi: 10.3389/fnbeh.2015.00272. eCollection 2015.
PubMed 26528154
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Changes in Posture Control and Cortex Activity Under a Dynamic Perturbation
- ClinicalTrials.gov ID
- NCT02706496
- Acronym / sponsor ID
- 2014-01-003C
- Conditions
- Aging
- Keywords
- aging of elderly, falling prevention, electroencephalography, postural control, biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Mar 2016 (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.
With aging, the elderly decreased ability to control postural balance will be accompanied by increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it increased with age (Skelton, \& Todd, 2004). In view of this, age-related posture control has become important issues of modern preventive medicine and family care.
Detailed description
Many clinical studies have been developed assessment tools and measurements for clinical staff to provide balanced assessment and intervention. However, the factors of affecting postural control are diverse and complex, not all tools or measurement could effectively detect a risk of falling. In daily living, the postural control involved integration of sensation, biofeedback, movement response, and kinesthetic sense to maintain postural stability, and finally integrated into the neuromuscular system and coordination to help achieve the perfect postural control. Current clinical tools used to assess the fall or research methods to detect the incidence of falls and the lack of effective relevant and contradictory, and it's difficult to effectively evaluate the risk of falls (Gates, et al, 2008).
With the development of postural balance issues associated with aging process in older people, there is no set of standardized equipment, and lack of effective methods for the assessment of normal and older people who fall. In response to these problems, if we can provide a virtual reality interfaces, and with daily living activities as gait, across obstacles activity, sit to stand, will be able to better meet the desire to explore the issue of real significance to enhance researchers for aging, motion analysis, and brain cortex activity mechanism in postural control mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young adults (20-35yr) | – | –The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. |
| middle age(45-60yr) | – | –The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. |
| elderly(65-74yr) | – | –The participants were first screened by the telephone interview, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The volunteers from the community will be recruited in this study, the inclusion criterion contained: able to walk and climb the stairs without assistive devices, could follow the instructions, and without well-known balance related diseases or impairments. With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study.
Key inclusion criteria (3 listed)
- able to walk and climb the stairs without assistive devices,
- could follow the instructions, and
- without well-known balance related diseases or impairments.
Key exclusion criteria (1 listed)
- With the disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular apparatus, dizziness experience or cognitive deficit would be excluded the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
center of pressure
Time frame: 3 minutes for 20 trial
0.5m pressure mat (RSscan, Inc., Belgium)
1 secondary outcome
cortex power spectrum density
Time frame: 3 minutes for 20 trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Results publication: PubMed 26528154Mierau A, Hulsdunker T, Struder HK. Changes in cortical activity associated with adaptive behavior during repeated balance perturbation of unpredictable timing. Front Behav Neurosci. 2015 Oct 14;9:272. doi: 10.3389/fnbeh.2015.00272. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Tsui-Fen Yang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Taipei Veterans General Hospital, Taiwan 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 3 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: finished, as of the sponsor's last update on 11 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
center of pressure (time frame: 3 minutes for 20 trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706496, which also lists 1 linked publication.
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 11 Mar 2016.