Overview

This trial is active, not recruiting.

Conditions postural control, subjective instablity
Treatments whole body vibration (galileo® med m plus, novotec, pforzheim, germany), physiotherapy
Sponsor Ludwig-Maximilians - University of Munich
Collaborator Medical University Innsbruck
Start date October 2012
End date April 2013
Trial size 60 participants
Trial identifier NCT01702597, 315-12, MMW-Stiftung

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
whole body vibration (galileo® med m plus, novotec, pforzheim, germany) WBV
Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.
(Active Comparator)
Patient will receive the current gold standard treatment protocol: supervised physical therapy, twice a week, 30 minutes per session, for 6 weeks.
physiotherapy Physical Therapy, Training
Patients will receive a standardized physical therapy.

Primary Outcomes

Measure
Postural control
time frame: 6 weeks

Secondary Outcomes

Measure
Subjective instability
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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

Additional Information

Official title The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -
Principal investigator Matthias Schieker, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.