Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT06161194
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2023-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will be randomly assigned to IG or CG after baseline assessment. Due to the nature of the studied conditions, it will not be possible to blind researchers or participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'cluster-randomized, two-arm parallel-group controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '3D-movement-analysis parameters (kinematic, kinetic, spatio-temporal)', 'timeFrame': 'Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery'}], 'primaryOutcomes': [{'measure': 'Frontal knee angle range of motion Pelvic obliquity angle range of motion Frontal trunk angle range of motion', 'timeFrame': 'Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery', 'description': 'Above listed angles derived from assessed Activities of Daily Living (ADL) tasks'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score (HHS) Hip Osteoarthritis Outcome Score (HOOS) Short-Form-Health Survey (SF12) International Physical Activity Questionnaire - short form (IPAQ) if applicable: Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline 4 weeks post-surgery; 3-months post-surgery; 6-months post-surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip replacement', 'exercise therapy', 'real-time feedback', 'movement analysis'], 'conditions': ['Hip Replacement']}, 'referencesModule': {'references': [{'pmid': '39163589', 'type': 'DERIVED', 'citation': 'Widhalm K, Maul L, Durstberger S, Putz P, Leder-Berg S, Kainz H, Augat P. Efficacy of Real-Time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: Protocol for a Pilot Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 20;13:e59755. doi: 10.2196/59755.'}]}, 'descriptionModule': {'briefSummary': 'This pilot cluster-randomized, two-arm parallel-group controlled trial, aims at enhancing the understanding of the effects of real-time feedback on functional deficits as knee valgus thrust, pelvic drop, and lateral trunk lean after total hip arthroplasty. Biomechanical and patient-reported outcomes will be assessed after a total hip arthroplasty as well as at three and six months follow-ups. The primary research question is, whether digital real-time feedback supported home-exercising improves the control of the frontal knee range of motion, pelvic obliquity, and lateral trunk lean, superior to exercising supported by written instructions as comparator. The secondary aspect focuses on potential differences between groups concerning aspects of quality of life, function, and physical activity. Tertiary functional outcomes between groups will be compared for reasons of quantification movement quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 50-75 years\n* body mass index from 18.5 to 29.99 kg/m²\n* able to walk without walking aids at baseline assessment\n* scheduled for elective unilateral total hip arthroplasty surgery\n* willing to comply with all study related procedures and provide informed consent\n\nExclusion Criteria:\n\n* symptoms of delayed healing concerning the implant\n* cardio-respiratory symptoms limiting exercise therapy (for example severe heart disease)\n* symptoms of musculoskeletal or cardio-respiratory overload\n* neuro-motor diseases (for example previous Stroke, Multiple Sclerosis, Morbus Parkinson Disease)\n* other reasons which would lead to obvious limitations concerning their participation in the intervention (for example severe contralateral osteoarthritis (OA), lower extremity fractures within previous 12 months, other elective lower extremity surgery within 6 months, inadequacy in German concerning questionnaires and exercise instructions, mentally unable to participate)\n* non-adherence (see definition under "therapeutic adherence").'}, 'identificationModule': {'nctId': 'NCT06161194', 'briefTitle': 'Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'FH Campus Wien, University of Applied Sciences'}, 'officialTitle': 'Efficacy of Real-time Feedback Exercise Therapy in Patients Following Total Hip Arthroplasty: a Pilot Cluster-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CIP_SETT_RCT-THA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (IG)', 'description': 'IG will perform the home-exercise program supported by the digital real-time exercise feedback prototype for digitally guided training.', 'interventionNames': ['Other: Supervised group exercise therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (CG)', 'description': 'The CG will perform a usual care home-exercise by means of printed hand-outs describing each exercise.', 'interventionNames': ['Other: Supervised group exercise therapy']}], 'interventions': [{'name': 'Supervised group exercise therapy', 'type': 'OTHER', 'description': 'Participants will participate in a 90 minutes supervised group exercise therapy program 2 times a week for 8 consecutive weeks.', 'armGroupLabels': ['Control Group (CG)', 'Intervention Group (IG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Orthopaedic Hospital Vienna Speising', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Klaus Widhalm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FH Campus Wien, University of Applied Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'The study protocol including the statistic analysis plan will be submitted for publication in Trials Journal at begin of 2024.\n\nThe final results will be submitted for publication to a relevant journal by the end of 2025.', 'ipdSharing': 'YES', 'accessCriteria': 'Open Access publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klaus Widhalm', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopedic Hospital Vienna Speising', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of study', 'investigatorFullName': 'Klaus Widhalm', 'investigatorAffiliation': 'FH Campus Wien, University of Applied Sciences'}}}}