BalanceWBV-USNCT04011423
Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People
A study testing Unstable shoes plus Whole-body vibration and Stable shoes plus Whole-body vibration in people with Balance, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Unstable shoes plus Whole-body vibration and Stable shoes plus Whole-body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2019to 24 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index < 35.
Who cannot join
- Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Balance
- Being tested
- Unstable shoes plus Whole-body vibration, Stable shoes plus Whole-body vibration
- Keywords
- Unstable Shoes, Whole Body Vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstable shoes plus Whole-body vibrationOther
Wearing unstable shoes during the whole-body vibration training
Stable shoes plus Whole-body vibrationOther
Wearing stable shoes during the whole-body vibration training
| Study group | Role | What they receive |
|---|---|---|
| Unstable shoes | Experimental | Wearing unstable shoes during the whole-body vibration training Receives: Other: Unstable shoes plus Whole-body vibration |
| Stable shoes | Active comparator | Wearing stable shoes during the whole-body vibration training Receives: Other: Stable shoes plus Whole-body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Velocity of the center of pressure assessed with a foot pressure sensitive walkway
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start20 Jul 2019
- Primary completion20 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011423
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-24
- Acronym
- WBV-US
- Status last verified
- Jan 2020
- First submitted
- 5 Jul 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29909231Lison 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.
PubMed 29333872
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People: A Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04011423
- Acronym / sponsor ID
- WBV-US / UNIVERSITY CARDENAL HERRERA-24
- Conditions
- Balance
- Keywords
- Unstable Shoes, Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable shoes | Experimental | Other: Unstable shoes plus Whole-body vibrationWearing unstable shoes during the whole-body vibration training |
| Stable shoes | Active comparator | Other: Stable shoes plus Whole-body vibrationWearing stable shoes during the whole-body vibration training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index < 35.
Key exclusion criteria (1 listed)
- Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unstable shoes plus Whole-body vibrationWearing unstable shoes during the whole-body vibration training | Other | Unstable shoes |
| Stable shoes plus Whole-body vibrationWearing stable shoes during the whole-body vibration training | Other | Stable shoes |
Primary outcome
Balance
Time frame: 4 weeks
Velocity of the center of pressure assessed with a foot pressure sensitive walkway
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Results publication: PubMed 29909231Salvador-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.
- Results publication: PubMed 29333872Lison 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JF Lisón, PhD principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstable shoes plus Whole-body vibration and Stable shoes plus Whole-body vibration in people with Balance, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.