AI-Assisted TelerehabiLitAtion System (ATLAS) for Post-discharge Continuation of Rehabilitative Care

The study team proposes ATLAS (AI-Assisted TelerehabiLitAtion System) a two-part solution. The first-Rebee AI-assisted telerehabilitation device-assists in inpatient rehabilitation, and allows patients to continue with their physical rehabilitation when discharged and waiting for Day Rehabilitation Centre (DRC). The second-a structured programme to train and familiarise patients and caregivers to Rebee over patients' Community Hospital (CH) inpatient rehabilitation stay-adopts an evidence-based approach to increase uptake and adherence to Rebee.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Deconditioning
• Intervention / Treatment: Device: Rebee

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lian Leng Low; Phone Number: +6563265872; Email: low.lian.leng@singhealth.com.sg
• Study Contact Backup: Name: Charmaine Tan; Phone Number: +6569703029; Email: charmaine.tan.y.m@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Rehabilitation Diagnostic Group (RDG): Total Knee Replacement / Deconditioning
2. Age 60 and above
3. Speak English/Mandarin
4. Able to follow instructions, no cognitive impairment
5. No MDRO (MultiDrug Resistant Organism)
6. Suitable and able to wear motion sensor on upper and lower limbs
7. Suitable and able to engage in Rebee exercises

Exclusion Criteria:

1. Not under RDG: Total Knee Replacement / Deconditioning
2. Below 60 years old
3. Unable to speak English/Mandarin
4. Cognitive impaired, unable to follow instructions
5. Has MDRO
6. Not suitable to wear motion sensor on upper and lower limbs
7. Refusal to participate / give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control - usual care; Business as usual in community hospital, no added device intervention
Experimental: Intervention - Rebee; Addition of Rebee device during and after community hospital stay	Device: Rebee; Tablet device with accompanying sensor device. Tablet device is preloaded with exercises, to be taught to patients during their hospital stay, and to be continued post-discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Barthel Index scores from baseline to 4, 8, and 12 weeks	Modified Barthel Index (MBI) measures ability to complete activities of daily living (ADLs). Scores range from 0 to 100. A higher score represents more independence, a lower score indicates more assistance needed (ie less independent). 0-20: Total dependence, 21-60: Severe dependence, 61-90: Moderate dependence, 91-99: Slight dependence, 100: Independence.	from recruitment (week 0) till end of study at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life scores from baseline to 4, 8, and 12 weeks	Quality of Life as measured using EQ-5D-5L. Has two components to this instrument: EQ-5D descriptive system1 to 5 for each dimensionA higher score represents "worse health status" (i.e., more severe problems with dimension).; EQ visual analogue scale (EQ VAS)0 to 100A higher score represents "better health status" (i.e., overall current health status).	from recruitment (week 0) till end of study at 12 weeks
Change in Patient Activation Level from baseline to 4, 8, and 12 weeks	Patient Activation Level measured using PAM-13 Score from 0 to 100 Higher scores indicate greater patient activation	from recruitment (week 0) till end of study at 12 weeks
Readmission rates to hospital within 30 days of discharge	e.g. 0 means no readmissions back to hospital within 30 days of discharge occured	within 30 days from discharge date
Change in Joint range of motion from baseline to 4, 8, and 12 weeks	Measured Joint Range of operated knee for patients with total knee replacement (TKR) Joint range will be measured for knee Extension and well as knee Flexion	from recruitment (week 0) till end of study at 12 weeks
Length of Stay in Community Hospital reported in days	Length of (inpatient) Stay in Community Hospital Reported in days, as measured by Discharge Date minus Admission Date e.g. if Discharge Date is 3/11/2024, and Admission Date is 1/11/2024, patient stayed for 2 days as an inpatient in the community hospital	From recruitment (week 0) till end of study at 12 weeks
Change in STS (sit to stand) score from baseline to 4, 8, and 12 weeks	Time taken to Sit to Stand 5 times, calculated in seconds A higher score represents taking a longer time to complete 5 times sit to stand.	from recruitment (week 0) till end of study at 12 weeks

Collaborators and Investigators

• Sponsor: SingHealth Community Hospitals
• Collaborators: Rebee Health; Jurong Community Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20242246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No