WBV and Acute Lateral Ankle Sprain (WBV and ALAS)

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

Study Overview

• Status: Unknown
• Conditions: Postural Control; Subjective Instablity
• Intervention / Treatment: Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany); Other: Physiotherapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WBV; 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.; Other Names: Galileo; WBV
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.	Other: Physiotherapy; Patients will receive a standardized physical therapy.; Other Names: Physical Therapy, Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural control	Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective instability	Patient recorded giving-way symptoms or recurrence	1 year

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Medical University Innsbruck
• Investigators: Principal Investigator: Matthias Schieker, Prof., Ludwig-Maximilians - University of Munich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (Estimate): October 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 8, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 315-12; MMW-Stiftung (Other Identifier: MMW-Stiftung)