HealthyNCT03443050
Training on Unstable Surfaces and Effects on the Balance of Healthy Young People
A study testing Unstable and Stable in people with Healthy, run by University of Valencia at 1 site in Spain.
Trial summary
The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Unstable and Stable
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 4 Apr 2018
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults aged between 18 and 30
Who cannot join
- Professional athlete
- Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)
- Known balance disorders including vertigo, central or vestibular limitations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training on Unstable Surfaces and Effects on the Balance of Healthy Young People, a Randomized Clinical Trial
The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those achieved with a training of similar characteristics, but implemented on a stable surface. An intensive program is proposed, whose target population is young adults.
- Conditions
- Healthy
- Being tested
- Unstable, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnstableOther
Also called Experimental
This group will train over unstable surfaces to enhance balance abilities
StableOther
Also called Control
This group will train over stable surface to enhance balance abilities
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Balance training on unstable surfaces Receives: Other: Unstable |
| Control | Active comparator | Balance training on stable surface Receives: Other: Stable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-balance test
Dynamic balance. The maximum length in cm achieved for each leg in the anterior, posterior-lateral and medial-lateral positions will be recorded.
Measured: change from baseline to end of intervention (4weeks)
Secondary outcomes (4)
Posturography (1)
A force T-plate platform will be used to assess posture in terms of sway area (mm2)
Measured: change from baseline to end of intervention (4weeks)
Posturography (2)
A force T-plate platform will be used to assess posture in terms of mean velocity (m/s)
Measured: change from baseline to end of intervention (4weeks)
Emery test
Static balance and proprioception as measured with the eyes closed to keep balance with one leg over an Airex(R) balance pad. The time in seconds will be recorded.
Measured: change from baseline to end of intervention (4weeks)
Functional reach
Test of stability, measured as the distance reached when leaning forward without falling (cm)
Measured: change from baseline to end of intervention (4weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2018
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
- Investigators
- Jose M Blasco, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443050
- Sponsor's protocol ID
- UNSTABLE_UV
- Status last verified
- Mar 2019
- First submitted
- 7 Feb 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training on Unstable Surfaces and Effects on the Balance of Healthy Young People, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03443050
- Acronym / sponsor ID
- UNSTABLE_UV
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 22 Feb 2018 (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.
The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those achieved with a training of similar characteristics, but implemented on a stable surface. An intensive program is proposed, whose target population is young adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: UnstableBalance training on unstable surfaces |
| Control | Active comparator | Other: StableBalance training on stable surface |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adults aged between 18 and 30
Key exclusion criteria (3 listed)
- Professional athlete
- Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)
- Known balance disorders including vertigo, central or vestibular limitations
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 |
|---|---|---|
| UnstableAlso: ExperimentalThis group will train over unstable surfaces to enhance balance abilities | Other | Experimental |
| StableAlso: ControlThis group will train over stable surface to enhance balance abilities | Other | Control |
Primary outcome
Y-balance test
Time frame: change from baseline to end of intervention (4weeks)
Dynamic balance. The maximum length in cm achieved for each leg in the anterior, posterior-lateral and medial-lateral positions will be recorded.
4 secondary outcomes
Posturography (1)
Time frame: change from baseline to end of intervention (4weeks)
Posturography (2)
Time frame: change from baseline to end of intervention (4weeks)
Emery test
Time frame: change from baseline to end of intervention (4weeks)
Functional reach
Time frame: change from baseline to end of intervention (4weeks)
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 7 Mar 2019.
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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.
Jose M Blasco, PhD principal investigator
University of Valencia
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 and Stable in people with Healthy, run by University of Valencia 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 3 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 7 Mar 2019. 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?
Y-balance test (time frame: change from baseline to end of intervention (4weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.