Deficit Elderly Women With Body BalanceNCT01040442
The Effect of Plantar Vibration Stimuli on the Balance of Older Women
A study testing vibration stimuli in people with Deficit Elderly Women With Body Balance, run by Universidade Federal de Sao Carlos.
Trial summary
The objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Deficit Elderly Women With Body Balance
- What is being tested?
- vibration stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Aug 2009
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged 60 or older, static balance deficit verified by the One-Leg Stance test with eyes open (OLSeo) (inability to maintain position for 30 seconds with eyes open, which is associated with the risk of falling17), independent gait without the use of walking aids.
Who cannot join
- individuals undergoing treatment to improve balance, inability to understand verbal commands, pathologies that affect balance and gait, use of medication that may affect balance, lower limb surgery in the past 12 months or participation in a physical activity program.
About this study
The objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance.
- Conditions
- Deficit Elderly Women With Body Balance
- Being tested
- vibration stimuli
- Keywords
- Postural Balance, Aging, Accidental Falls, Vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibration stimuliOther
A single physical therapist performed the intervention using a Novafon SK2‡ vibratory stimulation device at a frequency of 100 Hz and sway amplitude of 2 mm. The participants of the experimental group received vibratory stimulation, applied slowly by sliding the head of the device over the entire plantar region for ten minutes for each foot at every session. During the intervention, the participants remained in the supine position on an examination table.
| Study group | Role | What they receive |
|---|---|---|
| vibration stimuli | Experimental | Not described Receives: Other: vibration stimuli |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2009
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 Deficit Elderly Women With Body BalanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040442
- Sponsor's protocol ID
- fabio wanderley
- Status last verified
- Aug 2009
- First submitted
- 28 Dec 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Wanderley FS, Alburquerque-Sendin F, Parizotto NA, Rebelatto JR. Effect of plantar vibration stimuli on the balance of older women: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):199-206. doi: 10.1016/j.apmr.2010.10.014.
PubMed 21272715
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plantar Vibration Stimuli on the Balance of Older Women
- ClinicalTrials.gov ID
- NCT01040442
- Acronym / sponsor ID
- fabio wanderley
- Conditions
- Deficit Elderly Women With Body Balance
- Keywords
- Postural Balance, Aging, Accidental Falls, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Dec 2009 (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 objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vibration stimuli | Experimental | Other: vibration stimuli |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women aged 60 or older, static balance deficit verified by the One-Leg Stance test with eyes open (OLSeo) (inability to maintain position for 30 seconds with eyes open, which is associated with the risk of falling17), independent gait without the use of walking aids.
Key exclusion criteria (1 listed)
- individuals undergoing treatment to improve balance, inability to understand verbal commands, pathologies that affect balance and gait, use of medication that may affect balance, lower limb surgery in the past 12 months or participation in a physical activity program.
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 |
|---|---|---|
| vibration stimuliA single physical therapist performed the intervention using a Novafon SK2‡ vibratory stimulation device at a frequency of 100 Hz and sway amplitude of 2 mm. The participants of the experimental group received vibratory stimulation, applied slowly by sliding the head of the device over the entire plantar region for ten minutes for each foot at every session. During the intervention, the participants remained in the supine position on an examination table. | Other | vibration stimuli |
Primary outcome
Not reported in the source record.
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 29 Dec 2009.
- Derived from this study: PubMed 21272715Wanderley FS, Alburquerque-Sendin F, Parizotto NA, Rebelatto JR. Effect of plantar vibration stimuli on the balance of older women: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):199-206. doi: 10.1016/j.apmr.2010.10.014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing vibration stimuli in people with Deficit Elderly Women With Body Balance, run by Universidade Federal de Sao Carlos.
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 1 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 29 Dec 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040442, 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 29 Dec 2009.