Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-06 @ 7:23 PM
Study NCT ID:
NCT04687293
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2020-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabiliation Using HUBER 360 to Reduce the Risk of Falls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of falls, in seconds', 'timeFrame': '8 weeks', 'description': 'Measured with Timed-Up-and Go test'}], 'secondaryOutcomes': [{'measure': 'Physical performance', 'timeFrame': '8 weeks', 'description': 'Short Physical Performance Battery test (SPPB test). The test is scored from 0 (lower physical performance) to 12 (highest physical performance)'}, {'measure': 'Quality of life, measured with the Short Form-36 questionnaire', 'timeFrame': '8 weeks', 'description': 'SF-36 generic quality of life questionnaire. The score obtained from this questionnaire is composed with a Physcial component Scale (PMS) and a Mental component scale (MCS). Results are scored from 0 (worst quality of life) to 100 (best quality of life).'}, {'measure': 'Utility score using the EuroQol- 5 Dimension questionnaire', 'timeFrame': '8 weeks', 'description': 'Descriptive data from the 5 dimensions can be used to generate a health-related quality of life profile for the subject. The questionnaire is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Huber'], 'conditions': ['Rehabilitation', 'Exercise Therapy', 'Treatment Outcome', 'Quality of Life', 'Fall']}, 'descriptionModule': {'briefSummary': 'Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls.\n\nSubjects: any patient 1) benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF, Belgium; 2) presenting a pathological situation justifying functional rehabilitation with HUBER 360®; 3) presenting any pathology not constituting an exclusion criterion; 4) giving informed consent to research will be include in this 8-week interventional trial.\n\nDesign: randomized open-label trial. Patients will be randomized into the intervention group (HUBER trainig, 45 minutes of training, twice a week during 8 weeks) or in the control group (standard care).\n\nOutcomes: the effect of the training will be measured on the Time-Up-and-Go test, on the Short-Physical performance battery test and on quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF\n* Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®\n* Patient presenting any pathology not constituting an exclusion criterion\n* Patient giving informed consent to research.\n\nExclusion Criteria:\n\n* Cardiac or respiratory or neurological or rheumatological disease incompatible with physical activity ;\n* Joint inflammation;\n* Rheumatic disease in acute phase;\n* Recent trauma, infection of the musculoskeletal system;\n* Fever;\n* Venous thrombosis ;\n* Discopathy in acute phase;\n* Neuropsychological problems that do not allow to integrate the instructions or other serious psychological problems;\n* Cardiovascular diseases and any progressive, chronic, counter-indicative disease;\n* Large anatomical deformities.'}, 'identificationModule': {'nctId': 'NCT04687293', 'acronym': 'HUBER-FALLS', 'briefTitle': 'Rehabiliation Using HUBER 360 to Reduce the Risk of Falls', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Investigation of the Effectiveness of Rehabilitation Using the HUBER 360 Tool to Reduce the Risk of Falls in People in Pathological Situations Requiring Functional Rehabilitation', 'orgStudyIdInfo': {'id': 'HUBER_CNRF01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HUBER', 'description': 'HUBER is an isometric strengthening device. It consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed.\n\nIntervention will consist of 2 sessions of HUBER per week. Each session lasts approximatively 30 minutes. The intervention is 8 weeks long.', 'interventionNames': ['Device: HUBER (LPG Systems, France)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will not received any intervention except usual care.'}], 'interventions': [{'name': 'HUBER (LPG Systems, France)', 'type': 'DEVICE', 'description': "The HUBER® device consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed. It also comprises, two large handles with force sensors, mounted on a movable column. Its originality is based on its capacity to capture simultaneously the subjects' balance, core stability, core strength and total body strength; and adapt the training accordingly. Indeed, the platform interferes with the balance of the patient who must continually adjust his/her posture by exerting isometric pushing and pulling efforts with the arms. As a result, the device provides postural and muscle adaptation with visual feedback. Due to the constant adaptation of the device, it is thought to enhance muscular strength and improve neuromuscular coordination simultaneously.", 'armGroupLabels': ['HUBER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4557', 'city': 'Tinlot', 'state': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liège, CNRF', 'geoPoint': {'lat': 50.47493, 'lon': 5.37755}}], 'overallOfficials': [{'name': 'Jean-François Kaux, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Liege'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Charlotte Beaudart', 'investigatorAffiliation': 'University of Liege'}}}}