Balance; DistortedNCT01265134
Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly
An observational study of Balance; Distorted, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balance; Distorted
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Aug 2011
- 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 65 to 75 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: the elders
Who may be able to join
- no cognition problem. (mini-mental state examination [MMSE] > 23)
- no sensory or motor problem
- no use drugs about balance control
- lower extremity without any traumatic injury
Who cannot join
- Cognition impairment
- with specific neurological deficits resulting from neuropathy, neuromuscular disorders or spinal stenosis
- use drugs about balance control
- total joint arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly.
- Conditions
- Balance; Distorted
- Keywords
- the elders, falling, loss balance
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 |
|---|---|---|
| Experimental Group | the healthy elders | |
| Control Group | the elders who have fallen once |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startOct 2010
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance; DistortedStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chi-Hsien Chen, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265134
- Sponsor's protocol ID
- 99063
- Status last verified
- Dec 2010
- First submitted
- 21 Dec 2010
- Last updated
- 3 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly
- ClinicalTrials.gov ID
- NCT01265134
- Acronym / sponsor ID
- 99063
- Conditions
- Balance; Distorted
- Keywords
- the elders, falling, loss balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Study completion
- Aug 2011 (estimated)
- First posted
- 22 Dec 2010 (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 purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –the healthy elders |
| Control Group | – | –the elders who have fallen once |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- the elders
Key inclusion criteria (4 listed)
- no cognition problem. (mini-mental state examination [MMSE] > 23)
- no sensory or motor problem
- no use drugs about balance control
- lower extremity without any traumatic injury
Key exclusion criteria (4 listed)
- Cognition impairment
- with specific neurological deficits resulting from neuropathy, neuromuscular disorders or spinal stenosis
- use drugs about balance control
- total joint arthroplasty
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2011.
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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.
Chi-Hsien Chen principal investigator
Taipei Medical University WanFang Hospital
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 Balance; Distorted, run by Taipei Medical University WanFang 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 4 inclusion and 4 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 3 Jan 2011. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 3 Jan 2011.