Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation

NCT04352972 | Completed

• 1 other identifier: TA18may-0007
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy. The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Difference in Fast-paced gait speed

  Difference in fast gait speed (over 10 metres) between the two treatment groups.

  Pre-operation; 3 months and 6 months post-surgery

Secondary Outcomes (11)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Pre-operation; 3 months and 6 months post-surgery

• Quadriceps muscle strength

  Pre-operation; 3 months and 6 months post-surgery

• 30s chair stand test

  Pre-operation; 3 months and 6 months post-surgery

• Knee Pain: Numeric Pain Rating Scale (NPRS)

  Pre-operation; 3 months and 6 months post-surgery

• Knee range-of-motion

  Pre-operation; 3 months and 6 months post-surgery

Other Outcomes (1)

• Number of adverse events

  3 months and 6 months post-surgery

Study Arms (2)

Hospital-based rehabilitation program

ACTIVE COMPARATOR

Other: Hospital-based rehabilitation program

Tele-monitored home exercise program

EXPERIMENTAL

Device: Tele-monitored home exercise program

Interventions

Tele-monitored home exercise program DEVICE

Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.

Tele-monitored home exercise program

Hospital-based rehabilitation program OTHER

Participants will receive a maximum of 8 sessions over 10 weeks with the option of two additional sessions. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion. Participants will also receive a set of home exercises and they will be instructed to exercise on days when not attending rehabilitation.

Hospital-based rehabilitation program

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary unilateral total knee replacement
• Age \>= 45 years
• Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
• Ability to provide informed consent

You may not qualify if:

• Further lower limb joint replacement surgery anticipated within the next 6 months
• Rheumatoid arthritis and other systemic arthritis
• A previous history of stroke and other major neurological conditions
• An intention to transfer to step-down care facilities post-operatively.

Sponsors & Collaborators

• Singapore General Hospital: lead
• University of the Sunshine Coast: collaborator
• Duke University: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Monash University: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 168582, Singapore

Location

Related Publications (1)

• Pua YH, Koh SS, Terluin B, Woon EL, Chew ES, Yeo SJ, Chen JY, Liow LMH, Clark R, Thumboo J. Effect of Context Specificity on Response to the Shortened WOMAC Function Scale in Patients Undergoing Total Knee Arthroplasty. Arch Phys Med Rehabil. 2024 Sep;105(9):1725-1732. doi: 10.1016/j.apmr.2024.05.005. Epub 2024 May 7.

  PMID: 38723858 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the intervention, it is not feasible to blind participants or the treating physiotherapists. To reduce bias, the outcome assessor will be blinded to treatment allocation. Participants will also be instructed not to reveal details about their group assignment to the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 20, 2020
• Study Start: July 7, 2020
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

SG (1)