Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:50 AM
Study NCT ID:
NCT07464795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Kinesio Taping on Heel-Rise Endurance and Gastrocnemius Muscle Oxygenation in Healthy Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Concentric Work (J)', 'timeFrame': 'Measured during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Total concentric (positive) mechanical work (Joules) performed during a metronome-guided single-leg heel-rise test to task failure on the dominant limb. Work output will be measured using the Calf Raise App (computer-vision-based motion analysis).'}, {'measure': 'Percent Change in Gastrocnemius Muscle Oxygen Saturation at 20 Seconds (%ΔSmO₂_20s)', 'timeFrame': 'From baseline rest to 20 seconds during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)'}], 'secondaryOutcomes': [{'measure': 'Total number of single-leg heel-rise repetitions', 'timeFrame': 'Measured during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)'}, {'measure': 'Peak Heel-Rise Height (cm)', 'timeFrame': 'Measured during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Maximum heel-rise height (cm) achieved during the single-leg heel-rise test, measured using the Calf Raise App.'}, {'measure': 'Concentric Power (W)', 'timeFrame': 'Measured during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Mean concentric power output (Watts) generated during the single-leg heel-rise test, measured using the Calf Raise App.'}, {'measure': 'End-Exercise Muscle Oxygen Saturation (SmO₂_end)', 'timeFrame': 'Measured at task failure during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Muscle oxygen saturation (SmO₂) value recorded at the point of task failure during the heel-rise test.'}, {'measure': 'Half-Recovery Time (HRT) of SmO₂', 'timeFrame': 'Measured during the 4-minute post-exercise recovery period following the heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Time (seconds) required for muscle oxygen saturation (SmO₂) to recover to 50% of the difference between end-exercise SmO₂ and peak recovery SmO₂ during the standardized 4-minute recovery period.'}, {'measure': 'Percent Change in Total Hemoglobin at 20 Seconds (%ΔtHb_20s)', 'timeFrame': 'From baseline rest to 20 seconds during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Percentage change in total hemoglobin (tHb) at 20 seconds of the heel-rise test relative to baseline (tHb\\_rest), measured using near-infrared spectroscopy.'}, {'measure': 'Eccentric Work (J) During Single-Leg Heel-Rise Test', 'timeFrame': 'Measured during the single-leg heel-rise test in each experimental session (Day 1 and Day 2)', 'description': 'Total eccentric (negative) mechanical work (Joules) performed during the metronome-guided single-leg heel-rise test to task failure on the dominant limb, measured using the Calf Raise App.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endurance Calf Test', 'KINESIOTAPING']}, 'descriptionModule': {'briefSummary': 'acilitative kinesio taping (KT) is commonly used by athletes to support muscle performance and delay fatigue. However, evidence regarding its effects on muscle endurance and oxygenation remains inconsistent. This study aims to investigate the acute effects of facilitative KT applied to the gastrocnemius muscle on heel-rise endurance performance and local muscle oxygenation in healthy young adults.\n\nIn this randomized crossover trial, participants will complete two experimental sessions: one with facilitative kinesio taping and one with sham taping. After taping application, participants will perform a single-leg heel-rise test to task failure. Muscle oxygenation will be continuously monitored using a portable near-infrared spectroscopy device. The findings of this study may contribute to understanding whether kinesio taping has immediate physiological and performance-related effects on calf muscle endurance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young adults aged 18-25 years\n* Cumberland Ankle Instability Tool score of ≥28\n\nExclusion Criteria:\n\n* Sedentary (\\<150 min/week moderate or \\<75 min/week vigorous physical activity)\n* Elite athletes\n* History of ankle sprain\n* Lower extremity fracture\n* Surgical intervention\n* Neurological or vestibular disorders'}, 'identificationModule': {'nctId': 'NCT07464795', 'briefTitle': 'The Effects of Kinesio Taping on Heel-Rise Endurance and Gastrocnemius Muscle Oxygenation in Healthy Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Acute Effects of Kinesio Taping on Heel-Rise Endurance and Gastrocnemius Muscle Oxygenation: A Randomized Controlled Crossover Trial', 'orgStudyIdInfo': {'id': 'TU-FTR-MŞY-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facilitative Kinesio Taping', 'description': 'Participants will receive facilitative kinesio taping applied to the gastrocnemius muscle using a Y-shaped elastic tape with approximately 50% stretch. After application, participants will perform a single-leg heel-rise test to task failure.', 'interventionNames': ['Device: Kinesio Taping']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Taping', 'description': 'Participants will receive sham taping applied to the gastrocnemius muscle using a Y-shaped non-elastic tape without stretch. After application, participants will perform a single-leg heel-rise test to task failure.', 'interventionNames': ['Device: Sham Taping']}], 'interventions': [{'name': 'Kinesio Taping', 'type': 'DEVICE', 'description': 'Y-shaped Kinesio Tex elastic tape applied to the gastrocnemius muscle with approximately 50% stretch following muscle facilitation principles.', 'armGroupLabels': ['Facilitative Kinesio Taping']}, {'name': 'Sham Taping', 'type': 'DEVICE', 'description': 'Y-shaped Hypafix tape applied to the gastrocnemius muscle without stretch using the same anatomical configuration.', 'armGroupLabels': ['Sham Taping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Edirne', 'state': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'centralContacts': [{'name': 'Muhammed Şeref Yıldırım, PhD', 'role': 'CONTACT', 'email': 'muhammeds.yildirim@gmail.com', 'phone': '+905057443650'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant (PhD)', 'investigatorFullName': 'Muhammed Şeref Yıldırım', 'investigatorAffiliation': 'Trakya University'}}}}