Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 4:49 AM
Study NCT ID:
NCT06029361
Status:
UNKNOWN
Last Update Posted:
2023-09-08
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'an assessment will be made by questionnaires and an objective assessment by physiotherapists who will not be involved in the treatment of the SELFIT system in the interventional group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Independence Measure', 'timeFrame': '9 month', 'description': 'Measured by: Functional Independence Measure Index (FIM) that assess activity of daily living.\n\nonly motor assessment part is used. Minimum score 5 pts. Maximum score: 35 points.\n\nHigher score means better outcome'}, {'measure': '5 time sit to stand', 'timeFrame': '9 month', 'description': 'Assessment of time performance for five time stand up and sitting on chair. Less time means better outcome'}, {'measure': 'Berg Balance Test', 'timeFrame': '9 month', 'description': 'Assessment of balance function by 14 tasks. Min.0 max.56 points Higher score means better outcome.'}, {'measure': '10 Meter walk test', 'timeFrame': '9 month', 'description': 'Assessment of time performance of walking 10 meters. Less time means better outcome'}, {'measure': 'Falls Efficacy Scale', 'timeFrame': '9 month', 'description': 'Assessment of confidence of functions. Score range from 16 to 64 points. Higher score means better outcomes'}, {'measure': 'VAS - visual analog scale', 'timeFrame': '9 month', 'description': 'as mesured by a pain scale from 1 to 10. Lower score means better outcome'}, {'measure': 'PTPSQ-H physical therapy satisfaction questionnaire', 'timeFrame': '9 month', 'description': 'Hebrew approved version. 15 questions about patient satisfaction with physical therapy care. Score range about 15 to 75.\n\nHigher score means better outcomes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department.\n\nThe study population: 50 participants aged 65+ who were admitted to the geriatric rehabilitation department after hip fractures, with 25 in the experimental group and 25 in the control group.\n\nThe main question\\[s\\] it aims to answer are:\n\n* What is the effect of training with SELFIT system on the functional outcomes in patients after hip fractures hospitalized in the geriatric rehabilitation department.\n* How the training with SELFIT system will effect on satisfaction of the patients in the geriatric rehabilitation department.\n\nDuring 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.', 'detailedDescription': "Recruiting participants for the study:\n\nWhen admitting patients hospitalized in the geriatric rehabilitation department after hip neck fractures, their suitability for participation in the study will be examined according to inclusion and exclusion criteria. Patients who meet the inclusion criteria will receive an explanation of the research procedure and its goals, and if they agree and are suitable in terms of signature competence and cognitive ability to participate in the study, they will sign an informed consent form for participation in the study.\n\nAfter signing a consent form to participate in the study, each participant will be randomly assigned to an experimental group or a control group. After the patient agrees to participate in the study, he will receive a number that will be assigned in sequential order, where an even number means belonging to the experimental group and an odd number, belonging to the control group.\n\nIntervention:\n\nDuring 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.\n\nBoth groups will receive physiotherapy treatment accepted in the geriatric rehabilitation department. Patients in both groups receive treatment that focuses on improving strength in the lower limbs, improving ROM, lying and standing exercises, walking with an assistive device according to the patient's ability.\n\nIn the second and third week of rehabilitation, patients progress to exercises to improve walking ability, which include standing practice to improve strength and balance, walking with an aid for distances according to the adjustment of walking ability, dynamic balance practice on unstable surfaces and practice on stairs.\n\nPatients from the control group will receive standard treatment according to the patient's ability and the degrees of difficulty of the exercises will progress according to the ability of each patient. After the evaluation, the patients in the control group will receive an exercise in bed lying down or sitting to strengthen the lower limbs for about 15 minutes, an exercise in front of a bar to improve the strength of the lower limbs and the ability to stand up for about 15 minutes, an exercise to improve balance and walking for about 15 minutes.\n\nPatients from the experimental group will receive exercise in bed lying down or sitting to strengthen lower limbs for about 15 minutes, exercise in front of a bar to improve lower limb strength and the ability to stand up for about 15 minutes, exercise in the SELFIT system of balance and walking for about 15 minutes. The intervention in the SELFIT system will be carried out 4 times a week by a physiotherapist in the department."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to walk independently or under supervision before the fracture\n* Patients with full weight bearing on the operated leg according to the instructions of an orthopedic surgeon (FWB - Full Weight Bearing)\n* Patients who are able to walk with an assistive device FIM 3 and above (FIM Functional independence measure)\n* Mental competence after a comprehensive assessment by a Geriatric Specialist\n\nExclusion Criteria:\n\n* Patients with cognitive decline following dementia or delirium\n* Patients with complications after surgery - infection or bleeding in the surgical area\n* Patients with previous neurological injury or current CNS disease.\n* Patients with a previous lower limb fracture in the last 5 years.'}, 'identificationModule': {'nctId': 'NCT06029361', 'briefTitle': 'Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Improving Function and Mobility in Geriatric Patients After a Femoral Neck Fracture Who Are Undergoing Inpatient Rehabilitation Using an Augmented Reality Practice System - SELFIT', 'orgStudyIdInfo': {'id': '0003-22 MMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SELFIT device group', 'description': '25 patients in experimental group will receive 15 minutes with the SELFIT system during the 45 minutes of physical therapy', 'interventionNames': ['Device: Selfit Device group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '45 minutes of conventional physical therapy', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Selfit Device group', 'type': 'DEVICE', 'description': 'During 21 days, intervention group will receive physical therapy of 45 minutes which 15 minutes out of the 45 minutes will be with the SELFIT system', 'armGroupLabels': ['SELFIT device group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Conventional physical therapy of 45 minute', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4428163', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Alexander Protsenko, M.Sc.PT', 'role': 'CONTACT', 'email': 'alex.protsenko@clalit.org.il', 'phone': '972-9-7704326'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of physiotherapy of geriatric rehabilitation unit', 'investigatorFullName': 'Alexander Protsenko', 'investigatorAffiliation': 'Meir Medical Center'}}}}