WBV and Acute Lateral Ankle Sprain (WBV and ALAS)
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|ClinicalTrials.gov Identifier: NCT01702597|
Recruitment Status : Unknown
Verified October 2012 by Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich.
Recruitment status was: Active, not recruiting
First Posted : October 8, 2012
Last Update Posted : October 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postural Control Subjective Instablity||Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) Other: Physiotherapy||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2014|
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.
Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)
Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.
Active Comparator: Physiotherapy
Patient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks.
Patients will receive a standardized physical therapy.
Other Name: Physical Therapy, Training
- Postural control [ Time Frame: 6 weeks ]Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)
- Subjective instability [ Time Frame: 1 year ]Patient recorded giving-way symptoms or recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702597
|Principal Investigator:||Matthias Schieker, Prof.||Ludwig-Maximilians - University of Munich|