WBV and Acute Lateral Ankle Sprain (WBV and ALAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01702597
First received: October 3, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Postural Control
Subjective Instablity
Device: Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)
Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Postural control [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)


Secondary Outcome Measures:
  • Subjective instability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient recorded giving-way symptoms or recurrence


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • WBV
  • Galileo
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 Name: Physical Therapy, Training

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01702597

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Medical University Innsbruck
Investigators
Principal Investigator: Matthias Schieker, Prof. Ludwig-Maximilians - University of Munich
  More Information

No publications provided by Ludwig-Maximilians - University of Munich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastian. F. Baumbach, Principle Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01702597     History of Changes
Other Study ID Numbers: 315-12, MMW-Stiftung
Study First Received: October 3, 2012
Last Updated: October 4, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on October 23, 2014