- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06206668
Effect of Referent Type on Balance in Action Observation. (ROA)
March 5, 2026 updated by: Tania López Hernández, University Rovira i Virgili
Effect of Referent Type on Balance in Action Observation in Healthy People: Randomized Clinical Trial.
The objective of the study is to analyze whether observing the actions of a referent selected by the participants improves balance in asymptomatic individuals compared to those who observe a standard referent.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Design: Randomized controlled clinical trial. The primary endpoint of the study was the balance recorded by force platform (estatic) and Y balance test (dynamic).
Setting: The participants will be healthy people in the province of Tarragona.
Participants: They will be randomly assigned to one of three groups using a computerized randomized list:
- Control Group (CG): Participants will watch a video of landscapes without human or animal movement.
- Intervention Group with Referent (GIR): Participants will observe actions whose referent has been selected by themselves based on perceived similarity.
- Standard Intervention Group (GIE): Participants will observe actions with a standard reference.
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tarragona
-
Reus, Tarragona, Spain, 43203
- Centre Tecnològic de Nutrició i Salut Eurecat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be of legal age.
- Have a mobile device.
- Have normal or corrected-to-normal vision.
- Absence of neurological, orthopedic or vestibular disorders.
- Absence of specific balance skills due to competitive sports.
- Obtain a score of 3 or less on the Tegner activity scale.
- Having voluntarily signed the informed consent and being willing to follow the protocol proposed by the research team.
Exclusion Criteria:
- History of participation in any study with movement representation methods.
- Subjects with impaired communication and/or compression.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Participants will watch a video of landscapes without human or animal movement.
|
|
|
Experimental: Intervention Group with Referent (GIR)
Participants will observe actions whose referent has been selected by themselves based on perceived similarity.
A total of 16 different videos will be used, with 4 new videos each week.
The videos will gradually increase in difficulty as the study progresses.
All exercises are exercises used to improve balance.
|
The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.
|
|
Active Comparator: Standard Intervention Group (GIE)
Participants will observe actions with a standard reference.
In this case, a basic digitally designed faceless doll will be used.
A total of 16 different videos will be used, with 4 new videos each week.
The videos will gradually increase in difficulty as the study progresses.
All exercises are exercises used to improve balance.
|
The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static balance
Time Frame: 1 month
|
Center of pressure analysis: The displacement of the center of pressure (CPD) of the participants will be measured through posturographic tests performed on a force platform.
The following variables related to the center of pressure (CoP) will be calculated: the roll area (in square millimeters) and the distribution of the weight load on both sides.
|
1 month
|
|
Dynamic Balance
Time Frame: 1 month
|
A modified and abbreviated version of the Star Excursion Balance Test, known as mSEBT, will be used.
This test has been standardized and validated, and requires a board or floor with three lines indicating directions of movement: anterior (ANT), posteromedial (PM), and posterolateral (PL).
These lines form a Y, with an angle of 90° between PM and PL, and 135° between ANT and PM, and ANT and PL.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 1 day
|
Age will be measured in years
|
1 day
|
|
Biological sex
Time Frame: 1 day
|
Biological sex will be measured asking if they born like a boy or a girl.
|
1 day
|
|
Weight
Time Frame: 1 day
|
Weight will be measured in kg with a Beurer's body analyser scales
|
1 day
|
|
Height
Time Frame: 1 day
|
Height will be measured in cm.
|
1 day
|
|
Body mass index (BMI)
Time Frame: 1 day
|
Body mass index (BMI) will be measured in kg with a Beurer's body analyser scales
|
1 day
|
|
Length of the lower limb.
Time Frame: 1 day
|
Length of the lower limb will be measured in cm.
|
1 day
|
|
Dominant lower limb
Time Frame: 1 day
|
Dominant lower limb will be measured asking which limb would shoot a ball with.
|
1 day
|
|
Morphotype
Time Frame: 1 day
|
Morphotype (endomorph, ectomorph and mesoform) will be measured by observation
|
1 day
|
|
Trunk and lower extremity muscle strength
Time Frame: 1 month
|
Analogue dynamometry will be used as an evaluation method and will be recorded in Newtons (N) with the Saehan SKU SH5007 back, leg and chest dynamometer.
|
1 month
|
|
Satisfaction assessed by a selfcreate questionnaire
Time Frame: 1 day
|
A questionnaire specifically designed to evaluate participants' satisfaction with their experience in the study will be used once they have completed their participation.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cristina Adillón Camón, Dra., University Rovira i Virgili
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.
- Gatti R, Sarasso E, Pelachin M, Agosta F, Filippi M, Tettamanti A. Can action observation modulate balance performance in healthy subjects? Arch Physiother. 2019 Jan 22;9:1. doi: 10.1186/s40945-018-0053-0. eCollection 2019.
- Moon Y, Bae Y. The effect of backward walking observational training on gait parameters and balance in chronic stroke: randomized controlled study. Eur J Phys Rehabil Med. 2022 Feb;58(1):9-15. doi: 10.23736/S1973-9087.21.06869-6. Epub 2021 Sep 1.
- Picot B, Terrier R, Forestier N, Fourchet F, O.McKeon F. The Star Excursion Balance Test: An Update Review and Practical Guidelines. Int. J. Athl. Ther. Train. 2021 Jul 20,26(6):285-93. doi: 10.1123/ijatt.2020-0106.
- Cuenca-Martinez F, Suso-Marti L, Sanchez-Martin D, Soria-Soria C, Serrano-Santos J, Paris-Alemany A, La Touche R, Leon-Hernandez JV. Effects of Motor Imagery and Action Observation on Lumbo-pelvic Motor Control, Trunk Muscles Strength and Level of Perceived Fatigue: A Randomized Controlled Trial. Res Q Exerc Sport. 2020 Mar;91(1):34-46. doi: 10.1080/02701367.2019.1645941. Epub 2019 Oct 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
January 30, 2025
Study Registration Dates
First Submitted
December 31, 2023
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 16, 2024
Study Record Updates
Last Update Posted (Actual)
March 9, 2026
Last Update Submitted That Met QC Criteria
March 5, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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