HealthyNCT02615028
Development of Novel Designed Force Plate for Measuring the Balance Ability for the Elders
A study testing Closed eyes double-leg stance in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
To develop a force plate with a proper computing algorithm that can be used in the average household as well as within community care centers. An affordable price range will also be necessary. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Closed eyes double-leg stance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adults between 20 and 25 yrs
- Seniors between 67 to 75 yrs.
Who cannot join
- Lower limb neuromuscular diseases
- Musculoskeletal injuries
- Any negative response
About this study
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board
To develop a force plate with a proper computing algorithm that can be used in the average household as well as within community care centers. An affordable price range will also be necessary.
Read the detailed description
Many studies using force plates to examine the elders' balance ability for fall prevention. However, few studies compare the reliability differences among age in postural sway measurements even though many studies find significantly greater postural sway in the elder population than compared to the younger cohort. Investigation of this age difference is important for choosing variables to represent their postural sway improvement in order to determine the intervention outcome.
- Conditions
- Healthy
- Being tested
- Closed eyes double-leg stance
- Keywords
- Force plate, Balance ability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed eyes double-leg stanceOther
Closed eyes double-leg stance: Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Closed eyes double-leg stance | Other | Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds. Receives: Other: Closed eyes double-leg stance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure (COP)
Balance means the coordination module of transferring the center of pressure (COP).
Measured: 40 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
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 HealthyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Y Guo, Ph.D, Study chair, Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615028
- Sponsor's protocol ID
- KMUH-IRB-20120807
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Corriveau, H, Hébert R, Prince F, Raîche M. Postural control in the elderly: an analysis of test-retest and interrater reliability of the COP-COM variable. Arch Phys Med Rehabil 82(1): 80-85, 2001 Lafond D, Corriveau H, Prince F. Postural control mechanisms during quiet standing in patients with diabetic sensory neuropathy. Diabetes Care 27(1):173-178, 2004 Tinetti ME. Factors associated with serious injury during falls by ambulatory nursing home residents. J Am Geriatr Soc 35(7): 644-648, 1987. Woollacott MH, Shumway-Cook A, Nashner LM. Aging and posture control: changes in sensory organization and muscular coordination. Int J Aging Hum Dev 23(2): 97-114, 1986. 5. Sheldon JH. The effect of age on the control of sway. Gerontol Clin (Basel). 1963; 5: 129-138.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board
- ClinicalTrials.gov ID
- NCT02615028
- Acronym / sponsor ID
- KMUH-IRB-20120807
- Conditions
- Healthy
- Keywords
- Force plate, Balance ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Nov 2015 (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.
To develop a force plate with a proper computing algorithm that can be used in the average household as well as within community care centers. An affordable price range will also be necessary.
Detailed description
Many studies using force plates to examine the elders' balance ability for fall prevention. However, few studies compare the reliability differences among age in postural sway measurements even though many studies find significantly greater postural sway in the elder population than compared to the younger cohort. Investigation of this age difference is important for choosing variables to represent their postural sway improvement in order to determine the intervention outcome.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed eyes double-leg stance | Other | Other: Closed eyes double-leg stanceBody relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Young adults between 20 and 25 yrs
- Seniors between 67 to 75 yrs.
Key exclusion criteria (3 listed)
- Lower limb neuromuscular diseases
- Musculoskeletal injuries
- Any negative response
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 |
|---|---|---|
| Closed eyes double-leg stanceClosed eyes double-leg stance: Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds. | Other | Closed eyes double-leg stance |
Primary outcome
Center of Pressure (COP)
Time frame: 40 seconds.
Balance means the coordination module of transferring the center of pressure (COP).
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 25 Nov 2015.
- BackgroundCorriveau, H, Hébert R, Prince F, Raîche M. Postural control in the elderly: an analysis of test-retest and interrater reliability of the COP-COM variable. Arch Phys Med Rehabil 82(1): 80-85, 2001 Lafond D, Corriveau H, Prince F. Postural control mechanisms during quiet standing in patients with diabetic sensory neuropathy. Diabetes Care 27(1):173-178, 2004 Tinetti ME. Factors associated with serious injury during falls by ambulatory nursing home residents. J Am Geriatr Soc 35(7): 644-648, 1987. Woollacott MH, Shumway-Cook A, Nashner LM. Aging and posture control: changes in sensory organization and muscular coordination. Int J Aging Hum Dev 23(2): 97-114, 1986. 5. Sheldon JH. The effect of age on the control of sway. Gerontol Clin (Basel). 1963; 5: 129-138.
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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.
Lan Y Guo, Ph.D study chair
Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Closed eyes double-leg stance in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 2 inclusion and 3 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (COP) (time frame: 40 seconds.). 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 NCT02615028, 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 25 Nov 2015.