Effect of Referent Type on Balance in Action Observation.

Balance Disorders Clinical Trial

— ROA  

Official title:

Effect of Referent Type on Balance in Action Observation in Healthy People: Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206668
• Other study ID #: 01/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: University Rovira i Virgili
• Contact: Tania López Hernández
• Phone: +34620438175
• Email: tania.lopez[@]urv.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance Disorders

Intervention

Other:
• Action observation videos
The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.

Locations

Country	Name	City	State
Spain	Centre Tecnològic de Nutrició i Salut Eurecat	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static balance	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
Primary	Dynamic Balance	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	Age	Age will be measured in years	1 day
Secondary	Biological sex	Biological sex will be measured asking if they born like a boy or a girl.	1 day
Secondary	Weight	Weight will be measured in kg with a Beurer's body analyser scales	1 day
Secondary	Height	Height will be measured in cm.	1 day
Secondary	Body mass index (BMI)	Body mass index (BMI) will be measured in kg with a Beurer's body analyser scales	1 day
Secondary	Length of the lower limb.	Length of the lower limb will be measured in cm.	1 day
Secondary	Dominant lower limb	Dominant lower limb will be measured asking which limb would shoot a ball with.	1 day
Secondary	Morphotype	Morphotype (endomorph, ectomorph and mesoform) will be measured by observation	1 day
Secondary	Trunk and lower extremity muscle strength	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
Secondary	Satisfaction assessed by a selfcreate questionnaire	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