Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07176520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI-Assisted Rehabilitation In Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Functional Gain (AFG)', 'timeFrame': 'baseline, 3, 6, 9 and 12 weeks.', 'description': 'AFG= Functional score (at discharge/follow-up points) - functional score (at admission). Functional score is based on Modified Barthel Index (MBI).'}], 'secondaryOutcomes': [{'measure': 'Functional outcome: Short Physical Performance Battery (SPBB)', 'timeFrame': 'baseline, 3, 6, 9, 12-weeks', 'description': 'SPBB is a validated and commonly used tool to evaluate physical performance particularly in older adults. It is based on three timed tasks: gait speed (over short distance of 4 metres), balance tests (side-by-side, semi-tandem, and full-tandem), and repetitive chair sit-to-stand (strength and endurance) performance.45 It is an indicator of vulnerability, is associated with readmissions, and predictive of all-cause mortality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hybrid effectiveness-implementation study', 'pragmatic'], 'conditions': ['Frail']}, 'descriptionModule': {'briefSummary': "This study investigates the effectiveness and implementation of an AI-assisted rehabilitation tool for adults with frailty in the real-world. The main questions it aims to answer are:\n\nDoes AI-assisted rehabilitation among frail adults improve patients' physical outcomes? Is there a particular subgroup of frail subjects that will benefit most from AI-assisted rehabilitation?\n\nResearchers will compare AI-assisted rehabilitation to standard practice (advice and QR link for rehabilitation videos to be done at home) to see if AI-assisted rehabilitation improves clinical outcomes compared to standard practice.\n\nParticipants will either:\n\nUndergo an AI-assisted rehab with the AI-sensor tool or a standard practice post-discharge from community hospitals for 12 weeks.\n\nUndergo interval assessments of outcomes. Keep a diary of outpatient rehabilitations (if applicable for the subjects).", 'detailedDescription': 'This is a pragmatic, randomized controlled study on frail patients discharged from three community hospitals in Singapore.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥ 21years\n* Clinical Frailty Score (CFS) 4 to 6 \\*\n* Provided informed consent (for cognitively impaired persons MMSE\\<18, next-of-kin or proxy to give consent).\n* Have access to smartphone/tablet (own or loaned from investigators)/\n\nExclusion Criteria:\n\n* Medical conditions precluding safe home exercises or severely affect interaction with AI-tool (angina, vision loss, hearing impairment).\n* Cognitive impairment (MMSE\\<18) and no caregiver to assist with use of tool.\n* Participation in structured outpatient physiotherapy (\\>1 times/week), or day rehab programme.'}, 'identificationModule': {'nctId': 'NCT07176520', 'briefTitle': 'AI-Assisted Rehabilitation In Frailty', 'organization': {'class': 'OTHER', 'fullName': 'SingHealth Community Hospitals'}, 'officialTitle': 'AI-Assisted Rehabilitation for Frail Older Adults Discharged From Community Hospitals: A Hybrid Effectiveness-Implementation Trial', 'orgStudyIdInfo': {'id': '2025-1300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual care', 'description': 'Verbal and written discharge summary, advice, and referral to outpatient physiotherapy (if applicable)', 'interventionNames': ['Other: usual care only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AI-assisted rehabilitation', 'description': 'AI-assisted rehabilitation on top of usual care', 'interventionNames': ['Device: AI-assisted rehabilitation']}], 'interventions': [{'name': 'AI-assisted rehabilitation', 'type': 'DEVICE', 'description': 'Receives AI-assisted rehabilitation post-discharge at home in addition to usual care', 'armGroupLabels': ['AI-assisted rehabilitation']}, {'name': 'usual care only', 'type': 'OTHER', 'description': 'Verbal and written discharge summary, advice, and referral to outpatient physiotherapy (if applicable)', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chong Yau Clinical Asst Professor, MBBS', 'role': 'CONTACT', 'email': 'ong.chong.yau@singhealth.com.sg', 'phone': '6569703000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In accordance to my ethical board and institutional requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SingHealth Community Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jurong Community Hospital, Singapore', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ong Chong Yau', 'investigatorAffiliation': 'SingHealth Community Hospitals'}}}}