NCT03443050

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

February 7, 2018

Last Update Submit

March 6, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to end of intervention (4weeks)

Secondary Outcomes (4)

  • Posturography (1)

    change from baseline to end of intervention (4weeks)

  • Posturography (2)

    change from baseline to end of intervention (4weeks)

  • Emery test

    change from baseline to end of intervention (4weeks)

  • Functional reach

    change from baseline to end of intervention (4weeks)

Other Outcomes (2)

  • Jumping sideways test

    change from baseline to end of intervention (4weeks)

  • T-agility test

    change from baseline to end of intervention (4weeks)

Study Arms (2)

Experimental

EXPERIMENTAL

Balance training on unstable surfaces

Other: Unstable

Control

ACTIVE COMPARATOR

Balance training on stable surface

Other: Stable

Interventions

UnstableOTHER

This group will train over unstable surfaces to enhance balance abilities

Also known as: Experimental
Experimental
StableOTHER

This group will train over stable surface to enhance balance abilities

Also known as: Control
Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults aged between 18 and 30

You may not qualify if:

  • Professional athlete
  • Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)
  • Known balance disorders including vertigo, central or vestibular limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia. Facultat de Fisioterapia

Valencia, 46010, Spain

Location

Study Officials

  • Jose M Blasco, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 22, 2018

Study Start

March 1, 2018

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

ES(1)