A Pilot Feasibility Study Comparing Smartphone Home-based Rehabilitation Program Against the Usual Hospital and Outpatient Physiotherapy Care on Clinical and Cost Effectiveness for Total Knee Replacement Patients

Singapore Health Services (SingHealth)

Status: Not yet enrolling

Conditions: Knee Arthropathy

Treatments: Device: Smartphone application with tele-monitoring rehabilitation; Procedure: Hospital-based rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT06248034

2023/2482

Details and patient eligibility

About

Knee osteoarthritis (OA) is a common, chronic, and costly condition whilst total knee replacement (TKR) is a common orthopaedic surgical intervention. 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 smartphone home-based rehabilitation 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 randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of this innovative smartphone home-based exercise program versus that of currently standard, hospital-based outpatient rehabilitation program among post TKR patients in the Department of Physiotherapy, Singapore General Hospital.

Full description

Thirty patients undergoing TKR for knee OA will be randomly assigned to receive either smartphone home-based rehabilitation program or hospital-based rehabilitation program following surgery for a rehabilitation period of 24 weeks. The primary patient functional outcome will be fast gait speed. Outcomes will be assessed preoperatively, at 12-week and 24-week after surgery by an assessor masked to group allocation.

If shown to be non-inferior to the standard outpatient rehabilitation, smartphone home-based exercise program can be recommended as a cost effective treatment option for patients with TKR.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Primary unilateral total knee replacement
2. Age >= 45 years
3. Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
4. Able to ambulate independently without an assistive device
5. Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
6. Ability to provide informed consent
7. Able to operate phone application and use online platform
8. Able to read and understand English or Mandarin

Exclusion criteria

1. Rheumatoid arthritis and other systemic arthritis
2. Significant back or other non-knee pain
3. A previous history of stroke and other major neurological conditions
4. An intention to transfer to step-down care facilities post-operatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Participants for Smartphone Home-based Rehabilitation Program (N=15)

Experimental group

Description:

Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic.

Treatment:

Device: Smartphone application with tele-monitoring rehabilitation

Participants for Hospital-based rehabilitation program (N=15)

Experimental group

Description:

Study participants will be recruited from orthopaedic surgeons in Singapore General Hospital. Study participants will be recruited during their outpatient appointment session at the outpatient orthopaedic specialist clinic pre-admission clinic.

Treatment:

Procedure: Hospital-based rehabilitation program