Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-17 @ 9:37 AM
Study NCT ID:
NCT06845150
Status:
TERMINATED
Last Update Posted:
2025-12-08
First Post:
2025-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Compared to Sequential Cognitive and Physical Training in Anterior Cruciate Ligament Reconstructed Individuals
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': 'NONE', 'maskingDescription': 'concealed allocation of group'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Insufficient recruitment rate to reach the targeted number in June 2026', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kujala', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'The German version of the 13-item Kujala questionnaire will be used for assessment of anterior knee pain. Questions involve ability to do several activities and symptoms of patients. All scores of the 13 items are summed up to give a total score ranging from 0 to 100. High scores indicate a good outcome.'}, {'measure': 'ACL-Return to Sport after Injury Scale', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'The German version of the ACL-RSI will be used. The ACL-Return to Sport after Injury Scales includes 12 items which are each answered on a Likert-scale from 0 to 100. For the total score, individual scores of each item are added and subsequently divided by the numer of questions. Hence total score ranges from 0 to 120. High scores indicate a positive psychological evaluation.'}, {'measure': 'Tegner Activity Scale', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'The German version of the Tegner Activity Scale including 11 different stages will be used. Each stage includes activities in sports and work of patients after ACL injury. Stages range from 0 to 10.'}, {'measure': 'Socio-demographic data', 'timeFrame': 'Baseline', 'description': 'Sex, age, time since ACL reconstruction, injury history'}, {'measure': 'Subjective Cognitive Load', 'timeFrame': 'At the end of each training session (2x/week for 10 weeks)', 'description': 'Measured by the NASA-TLX questionnaire'}], 'primaryOutcomes': [{'measure': 'Interference', 'timeFrame': 'Baseline, after 5 weeks of training, after 10 weeks of training', 'description': 'Measured by the difference in reaction time of congruent and incongruent stimuli of the Flanker task.'}, {'measure': 'Response inhibition', 'timeFrame': 'Baseline, after 5 weeks of training, after 10 weeks of training', 'description': 'Measured by the accuracy of Go/No-Go-stimuli'}], 'secondaryOutcomes': [{'measure': 'Jumping performance - contact time', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'Contact time during jumping on force plates.'}, {'measure': 'Jumping performance - peak force', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'Peak force during jumping on force plates.'}, {'measure': 'Strength', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'Peak force of hamstring, quadriceps, hip abduction, and hip adduction'}, {'measure': 'Intrinsic motivation', 'timeFrame': 'At the end of each training session (2x/week for 10 weeks)', 'description': 'German version of the short scale for intrinsic motivation (Kurzskala Intrinsische Motivation). For each of the 12 items there is a 5-point Likert-Scale resulting in values of 0-4. Therefore, the total score ranges from 0 to 48. The higher the score, the higher the intrinsic motivation.'}, {'measure': 'Kinematics and kinetics of the lower extremities', 'timeFrame': 'During dual-task training in an immersive environment', 'description': 'Hip, knee, and ankle angles and moments and ground reaction forces'}, {'measure': 'Kinematics and kinetics of the lower extremities', 'timeFrame': 'Baseline and after 10 weeks of training', 'description': 'Ground reaction forces, angles and moments of hip, knee, and ankle during functional tasks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor-cognitive training', 'dual-task training', 'anterior cruciate ligament injury', 'return to competition'], 'conditions': ['Anterior Cruciate Ligament Reconstruction Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate changes in cognitive and physical performance after 10 weeks of dual or single task training in anterior cruciate ligament (ACL) reconstructed individuals. The main questions it aims to answer are:\n\n* Does cognitive performance in ACL reconstructed individuals change after multiple training sessions incorporating single versus dual-task?\n* Does physical performance and intrinsic motivation for training change over the course of 10 weeks when performing single versus dual-task training sessions?\n* What movement patterns do ACL reconstructed individuals show during a dual-task training in an immersive environment?\n\nResearchers will compare a combined dual-task training (combined physical and cognitive training) to a single task training (physical and cognitive training separately) to see if there are changes on cognitive performance depending on the training type.\n\nParticipants will:\n\n* Perform dual-task or single task training twice per week for 10 weeks\n* Visit the clinic before and after the training period for tests\n* Visit the movement laboratory once for analysis of movement patterns'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old\n* At least 6 months after ACL injury\n* Surgically reconstructed ACL\n* At least 2 hours of sports participation before the injury\n* Written consent of the attending surgeon to perform intensified training methods including one-legged jumps at 6 months after surgery after the first visit\n* Ability to give informed consent as documented by signature\n* Ability to understand instructions in German or English\n* BMI \\< 28 kg/m\\^2\n* Availability to take part in at least 70% of all training sessions\n\nExclusion Criteria:\n\n* Surgery on the contralateral leg during the last 12 months\n* Acute or chronic musculoskeletal, neurological, or cardiopulmonary disorders\n* Unadjusted vision problems\n* Concussion during the last 6 months\n* Pregnancy\n* Breastfeeding\n* Amputation\n* Inflammatory pain or swelling during exercising'}, 'identificationModule': {'nctId': 'NCT06845150', 'acronym': 'DUACL', 'briefTitle': 'Combined Compared to Sequential Cognitive and Physical Training in Anterior Cruciate Ligament Reconstructed Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Zurich University of Applied Sciences'}, 'officialTitle': 'Dual-Task Training in an Immersive Environment Compared to Single Task Training in Anterior Cruciate Ligament Reconstructed Individuals', 'orgStudyIdInfo': {'id': 'DUACL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual-task training', 'interventionNames': ['Other: Dual-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single task training', 'interventionNames': ['Other: Single task training']}], 'interventions': [{'name': 'Dual-task training', 'type': 'OTHER', 'description': 'Combined simultaneous physical and cognitive training in an immersive environment', 'armGroupLabels': ['Dual-task training']}, {'name': 'Single task training', 'type': 'OTHER', 'description': 'Sequential cognitive and then physical training', 'armGroupLabels': ['Single task training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'KSW Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8000', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'ZHAW Zurich University of Applied Sciences', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data will be shared if ethically and legally possible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michelle C. Haas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, {'name': 'ZHAW DIZH Fellowship Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Michelle C. Haas', 'investigatorAffiliation': 'Zurich University of Applied Sciences'}}}}