WBV and Acute Lateral Ankle Sprain

NCT01702597 | Unknown

• 2 other identifiers: 315-12MMW-Stiftung
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Postural Control; Subjective Instablity

Outcome Measures

Primary Outcomes (1)

• Postural control

  Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany)

  6 weeks

Secondary Outcomes (1)

• Subjective instability

  1 year

Study Arms (2)

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.

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.

Other: Physiotherapy

Interventions

Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany) DEVICE

Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.

Also known as: WBV, Galileo

WBV

Physiotherapy OTHER

Patients will receive a standardized physical therapy.

Also known as: Physical Therapy, Training

Physiotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Medical University Innsbruck: collaborator

Related Publications (1)

• 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.

  PMID: 23316791 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Matthias Schieker, Prof.

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 8, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 8, 2012

Record last verified: 2012-10