Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-04-13 @ 10:15 PM
Study NCT ID:
NCT05241795
Status:
UNKNOWN
Last Update Posted:
2022-03-18
First Post:
2022-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee vs. Ankle Training on Knee Mechanics After ACLR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2022-02-05', 'studyFirstSubmitQcDate': '2022-02-05', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment', 'timeFrame': 'baseline and 6 weeks posttreatment', 'description': 'Knee joint flexion torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.'}, {'measure': 'Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment', 'timeFrame': 'baseline and 6 weeks posttreatment', 'description': 'Knee joint extension torque (Nm/kg) in the supporting (stance) phase for each subject will be recorded using a 3D gait analysis system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Tear', 'ACL Sprain', 'Anterior Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate if there is any difference between starting rehabilitation program after ACL reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACL reconstruction with a hamstring tendon autograft participated in this study.\n* Score 7 on Tegner activity scale.\n\nExclusion Criteria:\n\n* Patients with bilateral knee injury\n* History of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity\n* History of ACL reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.'}, 'identificationModule': {'nctId': 'NCT05241795', 'briefTitle': 'Knee vs. Ankle Training on Knee Mechanics After ACLR', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ACL2122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Knee exercises then Ankle exercises', 'description': 'Patients will receive a rehabilitation protocol starting with knee training followed by ankle training.', 'interventionNames': ['Other: Knee then Ankle rehabilitation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Ankle exercises then Knee exercises', 'description': 'Patients will receive a rehabilitation protocol starting with ankle training followed by knee training.', 'interventionNames': ['Other: Ankle then Knee rehabilitation protocol']}], 'interventions': [{'name': 'Knee then Ankle rehabilitation protocol', 'type': 'OTHER', 'description': "Patients will start with knee exercise program that includes\n\n* Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.\n* Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.\n* Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.\n* Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.\n\nThen, Patients will start ankle exercises program that includes:\n\n* Standing calf raises\n* Foot lift\n* Ankle eversion exercises\n* Ankle Plantarflexion exercises", 'armGroupLabels': ['Group A: Knee exercises then Ankle exercises']}, {'name': 'Ankle then Knee rehabilitation protocol', 'type': 'OTHER', 'description': "Patients will start ankle exercises program that includes:\n\n* Standing calf raises\n* Foot lift\n* Ankle eversion exercises\n* Ankle Plantarflexion exercises\n\nThen, Patients will start with knee exercise program that includes\n\n* Partial Squats: The exercise will be performed as 3 sets of 10 repetitions each day.\n* Toe Raises: The exercise will be performed as 3 sets of 10 repetitions each day.\n* Stationary bike will be used (10-15 minutes /day) when the patients can bend their knees at least 100 degrees, as cycling is considered as an excellent conditioning and building exercise for the quadriceps muscles. As the patient's ability to pedal the bike with the operative leg improved, the therapist will increase the resistance.\n* Hamstring exercises: After 6 weeks, the hamstring muscles will be exercised by the patient pulling the heel back producing a hamstring contraction.", 'armGroupLabels': ['Group B: Ankle exercises then Knee exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Ashour, Ph.D', 'role': 'CONTACT', 'email': 'ahmed.ashour.pt@o6u.edu.eg', 'phone': '01001973275', 'phoneExt': '002'}], 'facility': 'October 6 University Hospital'}], 'centralContacts': [{'name': 'Ahmed A Ashour, Ph.D', 'role': 'CONTACT', 'email': 'ahmed.ashour.pt@o6u.edu.eg', 'phone': '01001973275', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'Participant data will be shared', 'accessCriteria': 'personal email: mohamed.magdy.pt@o6u.edu.eg'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohamed Magdy Ali Hassan ElMeligie', 'investigatorAffiliation': 'October 6 University'}}}}