Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT05081661
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-10-15', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': '26 Weeks', 'description': 'Fulfilled if the recruitment rate is above 50% of eligible patients per month.'}, {'measure': 'Enrolment rate', 'timeFrame': '38 Weeks', 'description': 'Fulfilled if the participation rate is \\> 75% (Percentage of participants who completed the study and the full programme, i.e. a minimum of eleven sessions out of twelve)'}], 'secondaryOutcomes': [{'measure': 'Dynamic postural control', 'timeFrame': '12 Weeks', 'description': 'Modified Star Excursion Balance Test (SEBT), average length in percent'}, {'measure': 'Static postural control', 'timeFrame': '12 Weeks', 'description': 'Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse'}, {'measure': 'Changes in the functional capacities of the operated knee', 'timeFrame': '12 Weeks', 'description': 'Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)'}, {'measure': 'Mental representation ability', 'timeFrame': '6 Weeks', 'description': 'Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)'}, {'measure': 'Use of Electrotherapy', 'timeFrame': '6 Weeks', 'description': 'Use of Electrotherapy during the rehabilitation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACL plasty', 'anterior cruciate ligament', 'motor imagery', 'postural control'], 'conditions': ['Anterior Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.', 'detailedDescription': 'Primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention.\n\nTwelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. The training sessions will last between 15 and 20 minutes. During each training session, the participant will note on his/her own "Tracking sheet" how long they listened to the audio and their comments. The "Tracking sheet" will document whether or not the patient has participated in each of the twelve sessions.\n\nIn parallel, a control group will follow a placebo programme according to the same formalities.\n\nTwenty-three participants (min.) will take part in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women of legal age\n* to be capable of discernment\n* to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs.\n* to have had an ACL surgery performed by the Doctor Siegrist within the last three days using the Hamstrings Tendon Graft or the Kenneth Jones method.\n\nExclusion Criteria:\n\n* not having a good spoken knowledge of the French language\n* recurrence of ACL injury in the same knee\n* meniscal sutures\n* associated fractures\n* pre-existing balance problems (tested at recruitment)\n* pre-existing neurological problems diagnosed by a doctor.'}, 'identificationModule': {'nctId': 'NCT05081661', 'briefTitle': 'Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA', 'organization': {'class': 'OTHER', 'fullName': 'HES-SO Valais-Wallis'}, 'officialTitle': 'The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility', 'orgStudyIdInfo': {'id': 'IM - CP - LCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motor Imagery Group A', 'description': 'This group will follow a program of motor imagery.', 'interventionNames': ['Other: Motor Imagery Program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Motor Imagery Group B', 'description': 'This group will follow a placebo program inspired from Bodyscan', 'interventionNames': ['Other: Placebo program']}], 'interventions': [{'name': 'Motor Imagery Program', 'type': 'OTHER', 'description': 'The intervention group of the study will undergo standard postoperative physical therapy treatment at their therapist. Beginning on the third day after surgery, the participant will begin an motor imagery program to be performed three times a week for four weeks. A session lasts between fifteen and twenty minutes. It begins with a body awareness phase followed by a series of three to five one-minute exercises to be repeated three times, with a one-minute break between each exercise. The program is performed independently at home using a standardized audio tape.', 'armGroupLabels': ['Motor Imagery Group A']}, {'name': 'Placebo program', 'type': 'OTHER', 'description': 'The control group of the study will undergo standard postoperative physiotherapy treatment at their therapist. On the third day after surgery, the participant will begin a relaxation program inspired by the mindfulness tool called Bodyscan that acts as a placebo mental imagery program. Nevertheless, the program created for this technique does not follow the Bodyscan guidelines (Jon Kabat-Zinn, 2005), as we do not want there to be any effects in favor of improved body perception on the participants, which could bring an additional biai to the study. For the sake of understanding, we have used the term "body visualization" in the various documents distributed to the participants. The program is to be performed three times a week for four weeks. A session lasts between ten and fifteen minutes. The program is performed independently at home using a standardized audio tape.', 'armGroupLabels': ['Motor Imagery Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1950', 'city': 'Sion', 'country': 'Switzerland', 'facility': 'Marielle.Pirlet', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}], 'overallOfficials': [{'name': 'Marielle Pirlet, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HES-SO Valais-Wallis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HES-SO Valais-Wallis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Physiotherapist - Senior lecturer', 'investigatorFullName': 'Marielle Pirlet', 'investigatorAffiliation': 'HES-SO Valais-Wallis'}}}}