Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 7:53 PM
Study NCT ID:
NCT06206668
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Referent Type on Balance in Action Observation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2023-12-31', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static balance', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Dynamic Balance', 'timeFrame': '1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': '1 day', 'description': 'Age will be measured in years'}, {'measure': 'Biological sex', 'timeFrame': '1 day', 'description': 'Biological sex will be measured asking if they born like a boy or a girl.'}, {'measure': 'Weight', 'timeFrame': '1 day', 'description': "Weight will be measured in kg with a Beurer's body analyser scales"}, {'measure': 'Height', 'timeFrame': '1 day', 'description': 'Height will be measured in cm.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '1 day', 'description': "Body mass index (BMI) will be measured in kg with a Beurer's body analyser scales"}, {'measure': 'Length of the lower limb.', 'timeFrame': '1 day', 'description': 'Length of the lower limb will be measured in cm.'}, {'measure': 'Dominant lower limb', 'timeFrame': '1 day', 'description': 'Dominant lower limb will be measured asking which limb would shoot a ball with.'}, {'measure': 'Morphotype', 'timeFrame': '1 day', 'description': 'Morphotype (endomorph, ectomorph and mesoform) will be measured by observation'}, {'measure': 'Trunk and lower extremity muscle strength', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Satisfaction assessed by a selfcreate questionnaire', 'timeFrame': '1 day', 'description': "A questionnaire specifically designed to evaluate participants' satisfaction with their experience in the study will be used once they have completed their participation."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Action observation', 'Referent', 'Gender', 'Balance'], 'conditions': ['Balance Disorders']}, 'referencesModule': {'references': [{'pmid': '30693101', 'type': 'BACKGROUND', '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.'}, {'pmid': '34468110', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '31938708', 'type': 'BACKGROUND', '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.'}, {'pmid': '31626568', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design: Randomized controlled clinical trial. The primary endpoint of the study was the balance recorded by force platform (estatic) and Y balance test (dynamic).\n\nSetting: The participants will be healthy people in the province of Tarragona.\n\nParticipants: They will be randomly assigned to one of three groups using a computerized randomized list:\n\n* Control Group (CG): Participants will watch a video of landscapes without human or animal movement.\n* Intervention Group with Referent (GIR): Participants will observe actions whose referent has been selected by themselves based on perceived similarity.\n* Standard Intervention Group (GIE): Participants will observe actions with a standard reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be of legal age.\n* Have a mobile device.\n* Have normal or corrected-to-normal vision.\n* Absence of neurological, orthopedic or vestibular disorders.\n* Absence of specific balance skills due to competitive sports.\n* Obtain a score of 3 or less on the Tegner activity scale.\n* Having voluntarily signed the informed consent and being willing to follow the protocol proposed by the research team.\n\nExclusion Criteria:\n\n* History of participation in any study with movement representation methods.\n* Subjects with impaired communication and/or compression.'}, 'identificationModule': {'nctId': 'NCT06206668', 'acronym': 'ROA', 'briefTitle': 'Effect of Referent Type on Balance in Action Observation.', 'organization': {'class': 'OTHER', 'fullName': 'University Rovira i Virgili'}, 'officialTitle': 'Effect of Referent Type on Balance in Action Observation in Healthy People: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '01/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will watch a video of landscapes without human or animal movement.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group with Referent (GIR)', 'description': '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.', 'interventionNames': ['Other: Action observation videos']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Intervention Group (GIE)', 'description': '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.', 'interventionNames': ['Other: Action observation videos']}], 'interventions': [{'name': 'Action observation videos', 'type': 'OTHER', 'description': 'The participant will see videos of balance exercises performed by the assigned reference, depending on their group, without performing any physical movement.', 'armGroupLabels': ['Intervention Group with Referent (GIR)', 'Standard Intervention Group (GIE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43203', 'city': 'Reus', 'state': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Tania López Hernández', 'role': 'CONTACT', 'email': 'tania.lopez@urv.cat', 'phone': '+34620438175'}], 'facility': 'Centre Tecnològic de Nutrició i Salut Eurecat', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}], 'centralContacts': [{'name': 'Tania López Hernández', 'role': 'CONTACT', 'email': 'tania.lopez@urv.cat', 'phone': '+34620438175'}], 'overallOfficials': [{'name': 'Cristina Adillón Camón, Dra.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Rovira i Virgili'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tania López Hernández', 'investigatorAffiliation': 'University Rovira i Virgili'}}}}