Distorted; BalanceNCT01045746
Effects of Whole-Body Vibration on Balance in the Elderly Population
A study testing Stochastic resonance whole-body vibration A and Stochastic resonance whole-body vibration b in people with Distorted; Balance, run by Bern University of Applied Sciences.
Trial summary
The goal of this pilot study is to test whether in the elderly population there are acute long-term improvements in both the static and dynamic balance, reaction time and mobility with the use of WBV. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Distorted; Balance
- What is being tested?
- Stochastic resonance whole-body vibration A and Stochastic resonance whole-body vibration b
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2010
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- BESA to include performance level 0,1,2.
- live in the senior residence Multengut Muri or in the canton of Bern.
- apart from the complaints of old age healthy and can stand with or without aids.
- more than 22 points at the Mini-Mental State Examination
Who cannot join
- Seniors / graduates may no severe, uncorrected visual disturbances (eg, low vision, double vision, skew deviation).
- Acute stress the incompatibility of the lower limb / hip / ridge during the SRT: joint disease, thrombosis, fresh fractures, infections, tissue damage, or fresh surgical scars.
- Seniors / inside with lower leg-/thigh prostheses.
- alcoholics.
About this study
Official title: Effects of Stochastic Resonance Therapy on Postural Control in the Elderly Population (Pilot Study)
The goal of this pilot study is to test whether in the elderly population there are acute long-term improvements in both the static and dynamic balance, reaction time and mobility with the use of WBV.
Read the detailed description
Exercise therapy plays an important role in health promotion, preservation of physical function and in preventing loss of independence among the elderly. They work beside an improvement in balance, a positive effect on metabolic and cardiovascular disorders, reducing falls, osteoporosis, colon cancer, breast cancer, depression, anxiety, and the general well-being. There is preliminary evidence to indicated that balance, and strength can be trained in the elderly using whole-body vibration (WBV) therapy. The use of WBV in the elderly population has shown to be a simple and effective treatment in the areas of balance and mobility. It would be very desirable to investigate these factors further in order to provide evidence for the delivery of sustainability of training methods.
- Conditions
- Distorted; Balance
- Being tested
- Stochastic resonance whole-body vibration A, Stochastic resonance whole-body vibration b
- Keywords
- whole-body vibration, stochastic resonance Therapy, static balance, balance, mobility, elderly, reaction time, The focus of the study is effect of SRT on postural balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic resonance whole-body vibration ADevice
Also called Zeptor med ®
over four weeks, three times a week with 5 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1.
Stochastic resonance whole-body vibration bDevice
Also called Zeptor med ®
over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 5 Hz, Noise 4.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | T0, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T1, 16 days wash-out period; T2, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T3 Receives: Device: Stochastic resonance whole-body vibration A; Device: Stochastic resonance whole-body vibration b |
| Group 2 | Experimental | T0, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T1, 16 days wash-out period;T2, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T3 Receives: Device: Stochastic resonance whole-body vibration A; Device: Stochastic resonance whole-body vibration b |
What is being measured
The primary outcome is the main question the study is designed to answer.
static balance
Measured: after one session, four and eight weeks
Secondary outcomes (2)
reaction time
Measured: after one session, after four and eight weeks
dynamic balance
Measured: after one session, four and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distorted; 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Maastricht University Medical Center, Goethe University
- Responsible party
- Principal investigator, Slavko Rogan, cand. PhD, PTMsc, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045746
- Sponsor's protocol ID
- PhD pilot study I
- Status last verified
- Dec 2014
- First submitted
- 8 Jan 2010
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rogan S, Hilfiker R, Schmid S, Radlinger L. Stochastic resonance whole-body vibration training for chair rising performance on untrained elderly: a pilot study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):468-73. doi: 10.1016/j.archger.2012.02.011. Epub 2012 Mar 16.
PubMed 22425243Rogan S, Radlinger L, Schmid S, Herren K, Hilfiker R & de Bruin ED. Skilling up for training: a feasibility study investigating acute effects of stochastic resonance whole-body vibration on postural control of older adults. Ageing Research. 2012;3(1):e5
Rogan S, Radlinger L, Hilfiker R, Schmidtbleicher D, de Bie RA, de Bruin ED. Feasibility and effects of applying stochastic resonance whole-body vibration on untrained elderly: a randomized crossover pilot study. BMC Geriatr. 2015 Mar 12;15:25. doi: 10.1186/s12877-015-0021-4.
PubMed 25886789
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stochastic Resonance Therapy on Postural Control in the Elderly Population (Pilot Study)
- ClinicalTrials.gov ID
- NCT01045746
- Acronym / sponsor ID
- PhD pilot study I
- Conditions
- Distorted; Balance
- Keywords
- whole-body vibration, stochastic resonance Therapy, static balance, balance, mobility, elderly, reaction time, The focus of the study is effect of SRT on postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Maastricht University Medical Center, Goethe University
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Jan 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 goal of this pilot study is to test whether in the elderly population there are acute long-term improvements in both the static and dynamic balance, reaction time and mobility with the use of WBV.
Detailed description
Exercise therapy plays an important role in health promotion, preservation of physical function and in preventing loss of independence among the elderly. They work beside an improvement in balance, a positive effect on metabolic and cardiovascular disorders, reducing falls, osteoporosis, colon cancer, breast cancer, depression, anxiety, and the general well-being. There is preliminary evidence to indicated that balance, and strength can be trained in the elderly using whole-body vibration (WBV) therapy. The use of WBV in the elderly population has shown to be a simple and effective treatment in the areas of balance and mobility. It would be very desirable to investigate these factors further in order to provide evidence for the delivery of sustainability of training methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Stochastic resonance whole-body vibration A, Device: Stochastic resonance whole-body vibration bT0, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T1, 16 days wash-out period; T2, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T3 |
| Group 2 | Experimental | Device: Stochastic resonance whole-body vibration A, Device: Stochastic resonance whole-body vibration bT0, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T1, 16 days wash-out period;T2, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T3 |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- BESA to include performance level 0,1,2.
- live in the senior residence Multengut Muri or in the canton of Bern.
- apart from the complaints of old age healthy and can stand with or without aids.
- more than 22 points at the Mini-Mental State Examination
Key exclusion criteria (4 listed)
- Seniors / graduates may no severe, uncorrected visual disturbances (eg, low vision, double vision, skew deviation).
- Acute stress the incompatibility of the lower limb / hip / ridge during the SRT: joint disease, thrombosis, fresh fractures, infections, tissue damage, or fresh surgical scars.
- Seniors / inside with lower leg-/thigh prostheses.
- alcoholics.
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 |
|---|---|---|
| Stochastic resonance whole-body vibration AAlso: Zeptor med ®over four weeks, three times a week with 5 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1. | Device | Group 1, Group 2 |
| Stochastic resonance whole-body vibration bAlso: Zeptor med ®over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 5 Hz, Noise 4. | Device | Group 1, Group 2 |
Primary outcome
static balance
Time frame: after one session, four and eight weeks
2 secondary outcomes
reaction time
Time frame: after one session, after four and eight weeks
dynamic balance
Time frame: after one session, four and eight weeks
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 23 Dec 2014.
- Results publication: PubMed 22425243Rogan S, Hilfiker R, Schmid S, Radlinger L. Stochastic resonance whole-body vibration training for chair rising performance on untrained elderly: a pilot study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):468-73. doi: 10.1016/j.archger.2012.02.011. Epub 2012 Mar 16.
- Results publicationRogan S, Radlinger L, Schmid S, Herren K, Hilfiker R & de Bruin ED. Skilling up for training: a feasibility study investigating acute effects of stochastic resonance whole-body vibration on postural control of older adults. Ageing Research. 2012;3(1):e5
- Derived from this study: PubMed 25886789Rogan S, Radlinger L, Hilfiker R, Schmidtbleicher D, de Bie RA, de Bruin ED. Feasibility and effects of applying stochastic resonance whole-body vibration on untrained elderly: a randomized crossover pilot study. BMC Geriatr. 2015 Mar 12;15:25. doi: 10.1186/s12877-015-0021-4.
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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.
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 Stochastic resonance whole-body vibration A and Stochastic resonance whole-body vibration b in people with Distorted; Balance, run by Bern University of Applied Sciences.
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: finished, as of the sponsor's last update on 23 Dec 2014. 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?
static balance (time frame: after one session, four and eight weeks). 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 NCT01045746, which also lists 3 linked publications.
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 23 Dec 2014.