Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:25 AM
Study NCT ID:
NCT07439861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Cognitive Dual-Task on Athletic Performance Parameters in Volleyball Players With and Without Chronic Ankle Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive test protocol', 'timeFrame': '1 day', 'description': "This protocol is designed to assess participants' attention, concentration, working memory, and mental calculation abilities. It is particularly used to evaluate the cognitive load accompanying motor performance within the dual-task paradigm. First, the test will be explained to the participants, after which a 20-second practice period will be provided. Subsequently, starting from a randomly determined number between 200 and 250 (excluding numbers ending in 7 and 0), participants will be asked to continue by verbally subtracting 7. While performing this subtraction, participants will be instructed to do so as accurately as possible, and the errors made during the test will be recorded."}, {'measure': 'Single-Leg Balance Test', 'timeFrame': '1 day', 'description': 'This test evaluates static postural control based on the number of errors made. Protocol Participants will be asked to stand barefoot on one leg with their hands placed on their hips. The supporting knee will be slightly flexed (approximately 10°), hands on the waist, and eyes closed, and they will be asked to maintain the balance position. Participants will attempt to maintain balance in this position for 20 seconds. Prior to the test, two practice trials will be performed for each foot for familiarization purposes.\n\nTest Termination The trial will be considered invalid and repeated if the participant removes their hands from their hips, flexes or abducts the thigh more than 30°, lifts the heel or forefoot of the supporting foot off the ground, is unable to maintain the test position for more than 5 seconds, or opens their eyes.\n\nMeasurement The test will be performed once for each lower extremity. The total number of errors made for each leg will be counted and recorded by the assesso'}, {'measure': 'Side Hop Test', 'timeFrame': '1 day', 'description': 'Protocol The test will be performed by having participants hop laterally on one leg across a distance of 30 cm. One repetition is defined as hopping 30 cm laterally and then returning to the starting point in the same manner. Each participant will be asked to complete 10 repetitions of this movement as quickly as possible.\n\nTest Termination The trial will be considered invalid and repeated if the participant falls, places the contralateral foot on the ground for support, or fails to fully exceed the 30 cm distance during hopping.\n\nMeasurement The time (seconds) required to complete 10 valid repetitions will be recorded. The validity and reliability of the test were found to be good, with a value of 0.84, as reported by Caffrey et al.'}, {'measure': 'Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)', 'timeFrame': '1 day', 'description': 'Protocol The participant will assume a push-up position with the hands placed on two parallel lines spaced 91.4 cm (36 inches) apart. During the test, the participant will lift one hand to touch the opposite line and then repeat the same movement with the other hand, performing as many touches as possible.\n\nMeasurement The total number of touches performed within 15 seconds will be recorded. The test will be conducted in three trials with 45 seconds of rest between trials, and the average of these three trials will be used as the final score.\n\nThe validity and reliability of the test were evaluated by Lee et al. and reported as 0.97.'}, {'measure': 'Spiking (Attack) Test', 'timeFrame': '1 day', 'description': 'A target measuring 2 meters in height and 1 meter in width will be placed on a wall located 7 meters away from the player. This target will be horizontally divided into five equal sections of 20 cm each. A coach will stand approximately 5 meters away from the approaching player to perform the spike and will deliver an overhead pass to the player. The players\' task will be to perform a spike approach and hit the ball toward this target. Scoring will be performed as follows: players who hit the central 20 cm section will receive 5 points; players who hit the two 20 cm sections adjacent to the central section will receive 3 points; and players who hit the two outermost 20 cm sections of the target will receive 1 point. If the ball successfully hits the boundary between two adjacent scoring zones, scores of 2 or 4 points will be recorded, respectively. Each player will perform 6 trials, and the total score obtained from these trials will be recorded as the player\'s "spiking accuracy score'}, {'measure': 'Forearm Pass (Passing) Test', 'timeFrame': '1 day', 'description': 'Players\' passing skills will be assessed by their ability to return a pass to a target positioned on the net, 2 m from the right sideline. The primary target (1.6 m high × 2.3 m wide) represents the approximate setter position during match play. A coach, positioned in the service area approximately 1 m above ground and 10 m from the player, delivers an overhead pass simulating a spiked ball. Players attempt to pass the ball to a teammate within the primary target area using an overhead forearm pass. Successful passes into this area receive 2 points.\n\nA secondary target area (3 m deep × 4.1 m wide) is defined for playable but less accurate passes and is awarded 1 point. Passes outside both areas receive 0 points. Each player completes six trials, and the total score represents the "passing accuracy score." The test demonstrates high reliability, with a reported test-retest coefficient of 0.94.'}, {'measure': 'Setting Test', 'timeFrame': '1 day', 'description': 'Players\' setting skills will be evaluated based on their ability to set the ball toward a circular target (80 cm diameter) positioned at net height, 5.5 m from the setter. This location represents the typical position of an attacker preparing to spike. A coach positioned 5 m from the setter delivers an overhead pass. Players attempt to set the ball into the target.\n\nScoring is as follows: successful passes through the target receive 3 points; passes contacting the edge receive 2 points; and passes crossing the net within 2.3 m of the net (approximately 1.5 m from the target center) receive 1 point. No points are awarded for unsuccessful attempts. Each player performs six trials, and the total score is recorded as the "setting accuracy score." The test shows high reliability, with a test-retest coefficient of 0.88.'}, {'measure': 'Serving Test', 'timeFrame': '1 day', 'description': 'Players\' serving skills will be evaluated based on their performance of serving the ball into a designated target area (9 meters in width) located in the opponent\'s court from the standard serving position. If the player successfully delivers the ball into the designated area (opponent\'s court), 1 point will be recorded. If the serve fails to reach the target area, such as landing outside the opponent\'s court or contacting the net, 0 points will be awarded. The total score obtained from 6 serving trials performed by each player will be recorded as the player\'s "serving accuracy score" (52).\n\nThe validity and reliability of the test were reported by Gabbett et al., with a test-retest reliability of 0.94.'}], 'secondaryOutcomes': [{'measure': 'Countermovement Jump Test', 'timeFrame': '1 day', 'description': 'Protocol Participants will start in an upright standing position with their hands placed on their hips, then they will be instructed to flex their knees as quickly as possible (approximately 90°) and, in the subsequent concentric phase, to jump as high as possible without performing any arm movement. Participants will be instructed to leave the ground by extending their knees and ankles during the jump and to land in a similarly extended position, and they will be asked to perform consecutive jumps as high and as quickly as possible for 15 seconds.\n\nMeasurement Three trials will be obtained with 30-second rest intervals between trials. Using the OptoGait photoelectric system (Microgate, Italy), the flight time (ms) of each jump will be recorded and converted into jump height (cm) by the system software. The average jump height of all jumps recorded within the 15-second period will be used as the performance score.'}, {'measure': 'Squat Jump Test', 'timeFrame': '1 day', 'description': 'Participants will start in an upright standing position with their hands placed on their hips, then they will be asked to flex their knees and maintain a predetermined knee position (approximately 90°). While the knees are held in the flexed position, the assessor will count for 3 seconds, after which participants will be instructed to jump as high as possible without performing any arm movement. Participants will be instructed to leave the ground by extending their knees and ankles during the jump and to land in a similarly extended position, and they will be asked to perform consecutive jumps as high and as quickly as possible for 15 seconds.\n\nThree trials will be obtained with 30-second rest intervals between trials. Using the OptoGait photoelectric system, the flight time (ms) of each jump will be recorded and converted into jump height (cm) by the system software. The average jump height of all jumps recorded within the 15-second period will be used as the performance score.'}, {'measure': 'Running Test', 'timeFrame': '1 day', 'description': 'A pair of OptoGait photoelectric systems (Microgate, Bolzano, Italy), each one meter in length, will be placed on both sides of a treadmill, at the same level as the contact surfaces. Participants will be asked to warm up by walking on the treadmill at their own comfortable, natural walking speeds and to become familiar with the treadmill. Data collection will be initiated after the participant reaches a constant speed of 2.78 m/s, and recordings will be obtained for a total duration of 1 minute, with the final 30 seconds taken into consideration.\n\nMeasured Parameters Ground contact time, step angle, flight time, step length, stride length, step frequency, and cadence.\n\nThe validity and reliability of the test were evaluated by Garcia-Pinillos et al., who reported a high level of agreement between systems in all examined spatiotemporal parameters (ICC \\> 0.89).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Ankle Instability', 'Chronic Ankle Instability, CAI', 'Volleyball', 'Volleyball Players']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of the cognitive dual-task on athletic performance parameters in volleyball players with and without chronic ankle instability. In addition, it will examine how a pathology in the lower extremity affects upper extremity function.', 'detailedDescription': 'This project is a cross-sectional and comparative study designed to investigate the effects of cognitive dual-task conditions on athletic performance parameters in volleyball players with and without chronic ankle instability (CAI). Chronic ankle instability is characterized by recurrent ankle sprains and a sensation of "giving way," and may lead to impairments in sensorimotor control, postural stability, and neuromuscular functions. Current approaches indicate that this pathology affects not only peripheral structures but also the central nervous system and cognitive processes. However, how CAI under cognitive load is reflected in upper extremity function through the kinetic chain has not been sufficiently investigated.\n\nVolleyball players aged between 18 and 25 years who are actively playing volleyball will be included in the study. Participants will be divided into two main groups: those with CAI and a healthy control group; the CAI group will also be classified as unilateral and bilateral. In all participants, static balance, dynamic balance, lower extremity strength, ankle dorsiflexion range of motion, upper extremity functional performance, and spatiotemporal parameters of running will be evaluated under single-task and cognitive dual-task conditions.\n\nThe originality of this study lies in addressing not only lower extremity functions in CAI but also upper extremity performance and its interaction with cognitive processes through the kinetic chain, using a holistic approach. The findings obtained are expected to clarify the role of cognitive load on athletic performance in individuals with CAI and to contribute to the planning of more functional and holistic athlete assessment and rehabilitation programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volleyball players with chronic ankle instability (CAI)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for players with CAI:\n\n* Chronic Ankle Instability Group Patients who meet all of the following criteria will be included in the study. The inclusion criteria defined by the International Ankle Consortium will be accepted.\n\n 1. Individuals must have been actively participating in the sport of volleyball for at least 5 years,\n 2. Individuals' first ankle sprain history must have occurred at least 1 year prior to the study and must have been associated with inflammatory symptoms (pain, swelling),\n 3. The most recent ankle sprain must have occurred 3 months or more before the start date of the study,\n 4. Athletes must have experienced a sensation of giving way at least twice within the past 6 months,\n 5. Athletes must have no history of ankle fracture,\n 6. Athletes must not have undergone any surgical procedures affecting sensorimotor function in the lower extremity and must have no internal diseases,\n 7. The score of the Identification of Functional Ankle Instability questionnaire must be greater than 11,\n 8. The Foot and Ankle Ability Measure score must be less than 90%,\n 9. The Foot and Ankle Ability Measure Sports subscale score must be less than 80%,\n 10. The Cumberland Ankle Instability Tool (CAIT) score must be less than 24,\n 11. The Foot and Ankle Outcome Score must be less than 75% in three or more categories.\n\nInclusion Criteria for players without CAI:\n\n1. Participation in volleyball training at least 3 days per week for 1 hour for a minimum of 5 years,\n2. A Cumberland Ankle Instability Tool score of 25 or higher,\n3. A Tegner activity level of 4 or higher,\n4. Absence of any systemic disease that could interfere with measurements.\n\nExclusion Criteria:\n\n1. Presence of rheumatic, neurological, or cardiovascular disease,\n2. History of ankle surgery,\n3. Musculoskeletal injury affecting the lower extremity within the last 6 months,\n4. Individuals who do not agree to participate in the study."}, 'identificationModule': {'nctId': 'NCT07439861', 'briefTitle': 'The Effect of Cognitive Dual-Task on Athletic Performance Parameters in Volleyball Players With and Without Chronic Ankle Instability', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effect of Cognitive Dual-Task on Athletic Performance Parameters in Volleyball Players With and Without Chronic Ankle Instability', 'orgStudyIdInfo': {'id': 'FTREK25/187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'volleyball players', 'description': 'volleyball players with CAI - volleyball players without CAI volleyball players with unilateral CAI - volleyball players with bilateral CAI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aynur DEMIREL, PT, PhD, Assoc. Prof.', 'role': 'CONTACT', 'email': 'aynur.demirel@hacettepe.edu.tr', 'phone': '+905545295057'}, {'name': 'Aynur Demirel, PT, PhD, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nurefsan BAYRAK, PT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Merve COMLEKCI, PT, MSc.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Aynur DEMIREL, PT, PhD, Assoc. Prof.', 'role': 'CONTACT', 'email': 'aynur.demirel@hacettepe.edu.tr', 'phone': '+905545295057'}, {'name': 'Nurefsan BAYRAK, PT', 'role': 'CONTACT', 'email': 'nurefsanbayrak25@hacettepe.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, PhD, Assoc. Prof.', 'investigatorFullName': 'Aynur Demirel', 'investigatorAffiliation': 'Hacettepe University'}}}}