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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206668
Other study ID # 01/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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