Equilibration Disorder, Vestibular NervePhase 2NCT01543243

Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control

A Phase 2 study testing Stochastic resonance whole-body vibration A and Stochastic resonance whole-body vibration B in people with Equilibration Disorder, Vestibular Nerve, run by Bern University of Applied Sciences at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to examine 1. the feasibility 2. immediately 3. long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Equilibration Disorder, Vestibular Nerve
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: 30 participants
Where: 1 siteSwitzerland
Study dates: Nov 2011to Dec 2012
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

RAI (Resident Assessment Instrument) >0
live in canton Bern
in terms of training load be resistant.

Who cannot join

acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute surgical scars
seniors with prosthesis.
alcoholic
acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
acute inflammation or infection tumors
fresh surgical wounds

Show all 9Show fewer

severe migraine
epilepsy
acute severe pain

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Bern University of Applied Science, Department Health
Bern, Canton of Bern, 3008

Other trials in Switzerland

About this study

Official title: Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control: a Pilot Study

This study aims to examine

the feasibility
immediately
long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

Read the detailed description

This study is based on the guideline of falls management exercise programs (FaME) designed exercise from Skelton and Dinan.

The FAME program is structured so that four biocybernetic pillars are embedded in the three successive stages of training.

The biocybernetic pillars:

improving the balance
improvement in functional capacity
improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
Training Gain: with the aim to improve functional abilities.
Maintaining the Gains: with the goal of muscle mass and bone density and introduce them to build complex multi-sensory exercises.

We started the FaME program with assistance from the pilot study, "Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Trial Registry: NCT01045746). It was found that a whole-body vibration with stochastic resonance (SR-WBV) enables that strength, coordination, and balance training while standing, in the exercise training gain phase is possible.

For this reason, this study will examine the feasibility and the immediately and long term effects of SR-WBV with 6 Hz, Noise 4 on postural control and strength in frail elderly.

Conditions: Equilibration Disorder, Vestibular Nerve
Being tested: Stochastic resonance whole-body vibration A, Stochastic resonance whole-body vibration B
Keywords: postural balance, strength

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 SRT Zeptor® med plus Noise
Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1.
Long term effect: over four weeks, three times a week with 6 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 SRT Zeptor® med plus Noise
Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4.
Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.

Study groups in NCT01543243
Study group	Role	What they receive
Group 1	Experimental	Group 1: immediate effects: T0, Stochastic resonance whole-body vibration A intervention, immediate T1 (one minute after Stochastic resonance whole-body vibration B intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration intervention, immediate T3 (one minute after Stochastic resonance whole-body vibration intervention) long term effect: T4, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T5, 16 days wash-out period; T6, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T7 Receives: Device: Stochastic resonance whole-body vibration A; Device: Stochastic resonance whole-body vibration B
Group 2	Experimental	Group 2: immediate effect: T0, Stochastic resonance whole-body vibration B intervention, immediate T1 (one minute after intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration A intervention, immediate T3 (one minute after intervention) Long term effect: T4, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T7 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.

Dynamic body balance
The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times.
Measured: effects after 4 weeks

Secondary outcomes (8)

static body balance
Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured.
Measured: immediate effects following one minute after a session of SR-WBV
static body balance
Semi-tandem stand (STS): Anterior-posterior (AP) and medial-lateral (ML) sway on a force plate during the STS will be measured.
Measured: effects after 4 weeks
dynamic body balance
The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times.
Measured: immediate effects following one minute after a session of SR-WBV
dynamic body balance
The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times
Measured: effects after 4 weeks
Lower extremity performance
Short physical performance battery (SPBB):The SPPB combines the results of balance tests (semi-tandem stand, side-by-side stand,full tandem stand), gait speed, and chair rise tests.
Measured: immediate effects following one minute after a session of SR-WBV
Lower extermity performance
Short physical performance battery (SPBB):The SPPB combines the results of balance tests (semi-tandem stand, side-by-side stand,full tandem stand), gait speed, and chair rise tests.
Measured: effects after 4 weeks
strength
Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).
Measured: immediate effects following one minute after a session of SR-WBV
strength
Muscle strength: It will be evaluated by five-sit-to-stand test and isometric rate of forcedevelopment and isometric Maximum Voluntary Contraction (MCV).
Measured: effects after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Dec 2012

First posted2 Mar 2012 (estimated)
Study startNov 2011
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Equilibration Disorder, Vestibular NerveStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01543243
Sponsor's protocol ID: PhD pilot study 2
Status last verified: Jun 2016
First submitted: 26 Sep 2011
Last updated: 14 Jun 2016
Results posted: No
Data monitoring committee: No

Publications

Rogan S, Schmidtbleicher D, Radlinger L. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study. Aging Clin Exp Res. 2014 Oct;26(5):519-27. doi: 10.1007/s40520-014-0212-4. Epub 2014 Apr 4.
PubMed 24700493
Rogan S, Radlinger L, Schmidtbleicher D, de Bie RA, de Bruin ED. Preliminary inconclusive results of a randomised double blinded cross-over pilot trial in long-term-care dwelling elderly assessing the feasibility of stochastic resonance whole-body vibration. Eur Rev Aging Phys Act. 2015 Oct 9;12:5. doi: 10.1186/s11556-015-0150-y. eCollection 2015.
PubMed 26865869

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control: a Pilot Study
ClinicalTrials.gov ID: NCT01543243
Acronym / sponsor ID: PhD pilot study 2
Conditions: Equilibration Disorder, Vestibular Nerve
Keywords: postural balance, strength
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Bern University of Applied SciencesUniversity, hospital or other
Collaborators: Goethe University, Maastricht University Medical Center, Swiss Federal Institute of Technology
Study start: Nov 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 2 Mar 2012 (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.

This study aims to examine

the feasibility
immediately
long term effects on postural control and strength of mechanical SR-WBV intervention in a frail elderly population.

Detailed description

This study is based on the guideline of falls management exercise programs (FaME) designed exercise from Skelton and Dinan.

The FAME program is structured so that four biocybernetic pillars are embedded in the three successive stages of training.

The biocybernetic pillars:

improving the balance
improvement in functional capacity
improvement in bone density and muscle mass Overthrowing 4) improving the security (reducing anxiety).

The training phase should reach the following goals:

Skilling up: with the aim of improving improve neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.
Training Gain: with the aim to improve functional abilities.
Maintaining the Gains: with the goal of muscle mass and bone density and introduce them to build complex multi-sensory exercises.

For this reason, this study will examine the feasibility and the immediately and long term effects of SR-WBV with 6 Hz, Noise 4 on postural control and strength in frail elderly.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Device: Stochastic resonance whole-body vibration A, Device: Stochastic resonance whole-body vibration BGroup 1: immediate effects: T0, Stochastic resonance whole-body vibration A intervention, immediate T1 (one minute after Stochastic resonance whole-body vibration B intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration intervention, immediate T3 (one minute after Stochastic resonance whole-body vibration intervention) long term effect: T4, Stochastic resonance whole-body vibration A intervention over four weeks, three time a week;T5, 16 days wash-out period; T6, Stochastic resonance whole-body vibration B intervention over four weeks, three times week, T7
Group 2	Experimental	Device: Stochastic resonance whole-body vibration A, Device: Stochastic resonance whole-body vibration BGroup 2: immediate effect: T0, Stochastic resonance whole-body vibration B intervention, immediate T1 (one minute after intervention), 7 days wash-out period; T2, Stochastic resonance whole-body vibration A intervention, immediate T3 (one minute after intervention) Long term effect: T4, Stochastic resonance whole-body vibration B intervention over four weeks, three time a week;T5, 16 days wash-out period;T6, Stochastic resonance whole-body vibration A intervention over four weeks, three times week, T7

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

RAI (Resident Assessment Instrument) >0
live in canton Bern
in terms of training load be resistant.

Key exclusion criteria (9 listed)

acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute surgical scars
seniors with prosthesis.
alcoholic
acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
acute inflammation or infection tumors

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: SRT Zeptor® med plus NoiseImmediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1. Long term effect: over four weeks, three times a week with 6 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: SRT Zeptor® med plus NoiseImmediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4. Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4.	Device	Group 1, Group 2

Primary outcome

Dynamic body balance
Time frame: effects after 4 weeks
The Expanded Timed Get Up-and-Go (ETGUG) will be used for measuring dynamic body balance. At 2, 8 and 10 meters along the walkway, markers were set, allowing to the measurement the change of the split times.

8 secondary outcomes

static body balance
Time frame: immediate effects following one minute after a session of SR-WBV
static body balance
Time frame: effects after 4 weeks
dynamic body balance
Time frame: immediate effects following one minute after a session of SR-WBV
dynamic body balance
Time frame: effects after 4 weeks
Lower extremity performance
Time frame: immediate effects following one minute after a session of SR-WBV
Lower extermity performance
Time frame: effects after 4 weeks
strength
Time frame: immediate effects following one minute after a session of SR-WBV
strength
Time frame: effects after 4 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 14 Jun 2016.
Results publication: PubMed 24700493Rogan S, Schmidtbleicher D, Radlinger L. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study. Aging Clin Exp Res. 2014 Oct;26(5):519-27. doi: 10.1007/s40520-014-0212-4. Epub 2014 Apr 4.
Results publication: PubMed 26865869Rogan S, Radlinger L, Schmidtbleicher D, de Bie RA, de Bruin ED. Preliminary inconclusive results of a randomised double blinded cross-over pilot trial in long-term-care dwelling elderly assessing the feasibility of stochastic resonance whole-body vibration. Eur Rev Aging Phys Act. 2015 Oct 9;12:5. doi: 10.1186/s11556-015-0150-y. eCollection 2015.

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.

Slavko Rogan, MSc study chair

Bern University of Applied Science, Department Health

Lorenz Radlinger, PhD principal investigator

Bern University of Applied Science, Department Health

Dietmar Schmidtbleicher, PhD, Prof. study director

Johann Wolfgang Goethe University Frankfurt am Main, Department Sport Science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 14 Jun 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 Switzerland. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Dynamic body balance (time frame: effects after 4 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 NCT01543243, which also lists 2 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 14 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.