Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 11:12 AM
Study NCT ID:
NCT06637592
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Windlass Versus Calcaneal Taping in Football Player With Plantar Fasciitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numeric pain rating scale', 'timeFrame': '1 week', 'description': 'This is a self-report assessment where participants evaluate their pain using a number scale. The scale normally spans from 0 to 10, where 0 signifies the absence of pain and 10 signifies the most severe agony imaginable.'}, {'measure': 'hubscher maneuver', 'timeFrame': '1 week', 'description': 'It is a method of evaluating the flexibility of a pes planus or flat foot type. The test is performed with the patient weight bearing, with the foot flat on the ground, while the clinician dorsiflexors the hallux and watches for an increasing concavity of the Arches of the foot'}, {'measure': 'calcaneal stance phase angle', 'timeFrame': '1 week', 'description': 'it is the sngle between calcaneal bisection and vertical line to floor when patient is standing erect on flat surface.'}, {'measure': 'lower extremity functional scale', 'timeFrame': '1 week', 'description': 'The Lower Extremity Functional Scale (LEFS) is a patient-reported instrument used to assess the level of functioning in cases of lower extremity musculoskeletal (MSK) disorders. The LEFS has 20 questions with scores ranging from 0 (severe difficulty/inability to execute activity) to 4 (no difficulties). The overall score can be calculated by adding the points for each item.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plantar fasciitis', 'taping'], 'conditions': ['Football Players']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Irfan S, Fiaz M. COMPARISON OF CALCANEAL TAPING AND SHAM TAPING IN SHORT TERM MANAGEMENT OF PAIN IN PLANTAR FASCIITIS; A RANDOMIZED CLINICAL TRIAL. Journal of Health and Rehabilitation Research. 2021;1(2):1-4'}, {'pmid': '33468002', 'type': 'BACKGROUND', 'citation': "Welte L, Kelly LA, Kessler SE, Lieberman DE, D'Andrea SE, Lichtwark GA, Rainbow MJ. The extensibility of the plantar fascia influences the windlass mechanism during human running. Proc Biol Sci. 2021 Jan 27;288(1943):20202095. doi: 10.1098/rspb.2020.2095. Epub 2021 Jan 20."}, {'pmid': '31714797', 'type': 'BACKGROUND', 'citation': 'Cobden A, Camurcu Y, Sofu H, Ucpunar H, Duman S, Kocabiyik A. Evaluation of the Association Between Plantar Fasciitis and Hallux Valgus. J Am Podiatr Med Assoc. 2020 Mar 1;110(2):Article_2. doi: 10.7547/17-150.'}]}, 'descriptionModule': {'briefSummary': "Plantar fasciitis is a prevalent ailment that affects the plantar fascia, a dense tissue strip that spans the underside of the foot, from the heel bone to the toes. Football players are especially susceptible to this ailment because of the sport's high-impact nature, which includes repetitive sprinting, jumping, and quick changes in direction. Taping has been used for many years for various ailments. The purpose of this study is to determine the effects of two taping techniques i.e. windlass taping and calcaneal taping on pain, flexibility and lower extremity function in football players.", 'detailedDescription': "The study will be a randomized clinical trial conducted at the Pakistan Sports Board and The Raider's football club over a duration of 10 months after synopsis approval. The required sample size for each group, after accounting for a 10% attrition rate, will be 17. Two study groups will be established: Group A, which will receive calcaneal taping among football players, and Group B, which will receive windlass taping among football players. Nonprobability purposive sampling will be employed. Data will be collected using the Numeric Pain Rating Scale (NPRS), Hubscher maneuver, goniometer, and lower extremity functional scale (LEFS) to assess pain severity, flat foot type flexibility, joint range of motion, and lower limb function, respectively. This comprehensive study aims to contribute valuable insights into the effects of calcaneal and windlass taping on football players."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive windlass test\n* Pain can appear after a period of intense training, normally declines with the warm up and reappears at the end of training.\n* Intense and acute heel pain localized primarily where plantar fascia attaches to the anterior calcaneus.\n* The pain presents on first walking in the morning or after a rest period.\n\nExclusion Criteria:\n\n* Congenital deformity of ankle and foot.\n* History of foot and ankle fracture.\n* History of ankle and foot surgery.\n* Previous surgery or treatment for plantar fasciitis in the previous 6 months.\n* Use of an assistive device for ambulation\n* Use of an assistive device for ambulation\n* Refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT06637592', 'briefTitle': 'Effects of Windlass Versus Calcaneal Taping in Football Player With Plantar Fasciitis.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Windlass Versus Calcaneal Taping on Pain, Flexibility and Lower Extremity Function in Football Player With Plantar Fasciitis.', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcaneal taping', 'description': 'Calcaneal taping is a method employed to offer assistance and relieve discomfort in the heel and ankle area. Start with a clean surface and apply first tape from lateral malleolus, pulling calcaneus in medial direction and attach to medial malleolus. Apply two more tapes in the same manner going distally. Apply an anchor tape at back of heel.', 'interventionNames': ['Other: Calcaneal taping']}, {'type': 'EXPERIMENTAL', 'label': 'Windlass taping', 'description': 'Begin by anchoring the tape just above the ball of the foot (metatarsal heads). Tear or cut a strip of tape, approximately 2-3 inches long, and place it horizontally around the foot, securing the starting point. Pull the tape diagonally across the bottom of the foot, aiming to support the arch. The tape should be applied with moderate tension to provide support without causing discomfort. While keeping tension on the tape, extend the big toe (great toe) upward. As the toe extends, the tape should tighten, activating the windlass mechanism and providing additional arch support.', 'interventionNames': ['Other: Windlass taping']}], 'interventions': [{'name': 'Calcaneal taping', 'type': 'OTHER', 'description': 'Calcaneal taping is a method employed to offer assistance and relieve discomfort in the heel and ankle area. Start with a clean surface and apply first tape from lateral malleolus, pulling calcaneus in medial direction and attach to medial malleolus. Apply two more tapes in the same manner going distally. Apply an anchor tape at back of heel.', 'armGroupLabels': ['Calcaneal taping']}, {'name': 'Windlass taping', 'type': 'OTHER', 'description': 'Begin by anchoring the tape just above the ball of the foot (metatarsal heads). Tear or cut a strip of tape, approximately 2-3 inches long, and place it horizontally around the foot, securing the starting point. Pull the tape diagonally across the bottom of the foot, aiming to support the arch. The tape should be applied with moderate tension to provide support without causing discomfort. While keeping tension on the tape, extend the big toe (great toe) upward. As the toe extends, the tape should tighten, activating the windlass mechanism and providing additional arch support.', 'armGroupLabels': ['Windlass taping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54700', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'NOT_YET_RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Asrar Yousaf, Mphil', 'role': 'CONTACT', 'email': 'Asrar.yousaf@riphah.edu.pk', 'phone': '03004099505'}, {'name': 'Maheen Shahid, MS-SPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Muhammad asrar Yousaf, Mphil', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Raiders football club', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '619', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Asrar Yousaf, Mphil', 'role': 'CONTACT', 'email': 'Asrar.yousaf@riphah.edu.pk', 'phone': '03004099505'}, {'name': 'Maheen Shahid, MS-SPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Muhammad Asrar Yousaf, Mphil', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pakistan sports board', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, Phd', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Muhammad Asrar Yousaf, Mphil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}