- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011423
Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People (WBV-US)
Effects of Combined Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People: A Preliminary Randomized Controlled Trial
Aim: To compare the effect of different type of shoes (unstable or stable) combined with a whole body vibration training on balance.
Design: Randomized controlled trial.
Setting: Laboratory of biomechanics.
Population: Healthy young people.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The use of whole body vibration to train strength and balance has increased in the last years. Last studies have shown that adding an unstable device increased electromyographic activity of the lower limb and the trunk muscles. However, no studies have investigated the effects of wearing unstable shoes during a whole-body vibration training on balance in healthy young people.
Aim: To compare the effects of different type of shoes (unstable [Intervention group] or stable [Control group]) combined with a 12-weeks whole body vibration training on balance.
Setting: Laboratory of biomechanics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index < 35.
Exclusion Criteria:
- Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Unstable shoes
Wearing unstable shoes during the whole-body vibration training
|
Wearing unstable shoes during the whole-body vibration training
|
|
ACTIVE_COMPARATOR: Stable shoes
Wearing stable shoes during the whole-body vibration training
|
Wearing stable shoes during the whole-body vibration training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 4 weeks
|
Velocity of the center of pressure assessed with a foot pressure sensitive walkway
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Salvador-Coloma P, Arguisuelas MD, Domenech-Fernandez J, Sanchez-Zuriaga D, Amer-Cuenca JJ, Martinez-Gramage J, Montanez-Aguilera FJ, Lison JF. Effects of unstable shoes on trunk muscle activity in patients with chronic low back pain. Gait Posture. 2018 Jul;64:165-168. doi: 10.1016/j.gaitpost.2018.06.025. Epub 2018 Jun 11.
- Lison JF, Ortega-Santana B, Anton-Nogues A, Gonzalez-Requena P, Vera-Hervas C, Domenech-Fernandez J, Sanchez-Zuriaga D, Salvador-Coloma P. Effects and underlying mechanisms of unstable shoes on chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 May;32(5):654-662. doi: 10.1177/0269215517753972. Epub 2018 Jan 14.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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