Postural ControlWBV and ALASNCT01702597
WBV and Acute Lateral Ankle Sprain
A study testing Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) and Physiotherapy in people with Postural Control and Subjective Instablity, run by Ludwig-Maximilians - University of Munich.
Trial summary
The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Control, Subjective Instablity
- What is being tested?
- Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Apr 2014
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)
Who cannot join
- Pregnancy
- Conditions affecting the neuromuscular- or musculoskeletal System
- Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI
- Conditions possibly affecting balance
- Cardiovascular disease including thrombosis
- Respiratory diseases
Show all 14Show fewer
- Abdominal diseases (including gallstones)
- Urological diseases (including kidney- and bladder stones)
- Gynaecological diseases and + intrauterine devices
- Neurological diseases including epilepsia within the last 2 years
- Acute injuries to the head
- Patient is not available for follow up visits
- Patient unable to give informed consent
- Patient suspected to be non-compliant
About this study
Official title: The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -
The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months
Read the detailed description
Background:
Ankle sprains often result in ankle instability, which is most likely caused by damage to passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training method improving those neurologic parameters impaired. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.
Methods/Design:
60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Patients will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-depending weight bearing, limited functional immobilization by orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform similar exercises on a side-alternating sinusoidal vibration platform as the control group. Two time dependent primary outcome parameters will be assessed. Short-term outcome after six weeks will be postural control quantified by the sway index. Mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include return to pre-injury level of activities, residual pain, recurrence, objective instability, energy / coordination, Foot and Ankle Disability Index and EQ 5D.
- Conditions
- Postural Control, Subjective Instablity
- Being tested
- Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany), Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)Device
Also called WBV, Galileo
Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.
PhysiotherapyOther
Also called Physical Therapy, Training
Patients will receive a standardized physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| WBV | Experimental | Patients will receive supervised physical therapy using a whole body vibration device (Galileo® Med M Plus, Novotec, Pforzheim, Germany) twice a week, 30 minutes per session, for 6 weeks. Receives: Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) |
| Physiotherapy | Active comparator | Patient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)
Measured: 6 weeks
Secondary outcomes (1)
Subjective instability
Patient recorded giving-way symptoms or recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2014 (estimated)
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 Postural ControlStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Principal investigator, Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
- Investigators
- Matthias Schieker, Prof., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702597
- Sponsor's protocol ID
- 315-12
- Other IDs
- MMW-Stiftung
- Acronym
- WBV and ALAS
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumbach SF, Fasser M, Polzer H, Sieb M, Regauer M, Mutschler W, Schieker M, Blauth M. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial. BMC Musculoskelet Disord. 2013 Jan 14;14:22. doi: 10.1186/1471-2474-14-22.
PubMed 23316791
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -
- ClinicalTrials.gov ID
- NCT01702597
- Acronym / sponsor ID
- WBV and ALAS / 315-12
- Conditions
- Postural Control, Subjective Instablity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 8 Oct 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.
The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months
Detailed description
Background:
Ankle sprains often result in ankle instability, which is most likely caused by damage to passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training method improving those neurologic parameters impaired. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.
Methods/Design:
60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Patients will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-depending weight bearing, limited functional immobilization by orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform similar exercises on a side-alternating sinusoidal vibration platform as the control group. Two time dependent primary outcome parameters will be assessed. Short-term outcome after six weeks will be postural control quantified by the sway index. Mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include return to pre-injury level of activities, residual pain, recurrence, objective instability, energy / coordination, Foot and Ankle Disability Index and EQ 5D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBV | Experimental | Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)Patients will receive supervised physical therapy using a whole body vibration device (Galileo® Med M Plus, Novotec, Pforzheim, Germany) twice a week, 30 minutes per session, for 6 weeks. |
| Physiotherapy | Active comparator | Other: PhysiotherapyPatient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)
Key exclusion criteria (14 listed)
- Pregnancy
- Conditions affecting the neuromuscular- or musculoskeletal System
- Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI
- Conditions possibly affecting balance
- Cardiovascular disease including thrombosis
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 |
|---|---|---|
| Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)Also: WBV, GalileoPatients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs. | Device | WBV |
| PhysiotherapyAlso: Physical Therapy, TrainingPatients will receive a standardized physical therapy. | Other | Physiotherapy |
Primary outcome
Postural control
Time frame: 6 weeks
Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)
1 secondary outcome
Subjective instability
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
- Derived from this study: PubMed 23316791Baumbach SF, Fasser M, Polzer H, Sieb M, Regauer M, Mutschler W, Schieker M, Blauth M. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial. BMC Musculoskelet Disord. 2013 Jan 14;14:22. doi: 10.1186/1471-2474-14-22.
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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.
Matthias Schieker, Prof. principal investigator
Ludwig-Maximilians - University of Munich
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) and Physiotherapy in people with Postural Control and Subjective Instablity, run by Ludwig-Maximilians - University of Munich.
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 14 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 8 Oct 2012. 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?
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.
What does the primary outcome measure?
Postural control (time frame: 6 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 NCT01702597, 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 8 Oct 2012.