- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07176520
- Original Trial
AI-Assisted Rehabilitation In Frailty
AI-Assisted Rehabilitation for Frail Older Adults Discharged From Community Hospitals: A Hybrid Effectiveness-Implementation Trial
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:
Does 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?
Researchers 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.
Participants will either:
Undergo an AI-assisted rehab with the AI-sensor tool or a standard practice post-discharge from community hospitals for 12 weeks.
Undergo interval assessments of outcomes. Keep a diary of outpatient rehabilitations (if applicable for the subjects).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chong Yau Clinical Asst Professor, MBBS
- Phone Number: 6569703000
- Email: ong.chong.yau@singhealth.com.sg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged ≥ 21years
- Clinical Frailty Score (CFS) 4 to 6 *
- Provided informed consent (for cognitively impaired persons MMSE<18, next-of-kin or proxy to give consent).
- Have access to smartphone/tablet (own or loaned from investigators)/
Exclusion Criteria:
- Medical conditions precluding safe home exercises or severely affect interaction with AI-tool (angina, vision loss, hearing impairment).
- Cognitive impairment (MMSE<18) and no caregiver to assist with use of tool.
- Participation in structured outpatient physiotherapy (>1 times/week), or day rehab programme.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Usual care
Verbal and written discharge summary, advice, and referral to outpatient physiotherapy (if applicable)
|
Verbal and written discharge summary, advice, and referral to outpatient physiotherapy (if applicable)
|
|
Active Comparator: AI-assisted rehabilitation
AI-assisted rehabilitation on top of usual care
|
Receives AI-assisted rehabilitation post-discharge at home in addition to usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute Functional Gain (AFG)
Time Frame: baseline, 3, 6, 9 and 12 weeks.
|
AFG= Functional score (at discharge/follow-up points) - functional score (at admission).
Functional score is based on Modified Barthel Index (MBI).
|
baseline, 3, 6, 9 and 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional outcome: Short Physical Performance Battery (SPBB)
Time Frame: baseline, 3, 6, 9, 12-weeks
|
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.
|
baseline, 3, 6, 9, 12-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-1300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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