Postural Control Clinical Trial
— WBV and ALASOfficial title:
The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -
Verified date | October 2012 |
Source | Ludwig-Maximilians - University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | April 2014 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich | Medical University Innsbruck |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postural control | Sway Index measured via the Leonardo Mechanograph GRFP (16 bit, 800 Hz; NOVOTEC Medical GmbH, Germany) | 6 weeks | No |
Secondary | Subjective instability | Patient recorded giving-way symptoms or recurrence | 1 year | No |
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