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
- Conditions
- Knee Arthropathy
- Interventions
- Device: Smartphone application with tele-monitoring rehabilitationProcedure: Hospital-based rehabilitation program
- Registration Number
- NCT06248034
- Lead Sponsor
- Singapore General Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Primary unilateral total knee replacement
- Age >= 45 years
- Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
- Able to ambulate independently without an assistive device
- Willingness to be randomized to either smartphone home-based rehabilitation program or outpatient rehabilitation
- Ability to provide informed consent
- Able to operate phone application and use online platform
- Able to read and understand English or Mandarin
- Rheumatoid arthritis and other systemic arthritis
- Significant back or other non-knee pain
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants for Smartphone Home-based Rehabilitation Program (N=15) Smartphone application with tele-monitoring rehabilitation 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. Participants for Hospital-based rehabilitation program (N=15) Hospital-based rehabilitation program 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.
- Primary Outcome Measures
Name Time Method Gait speed: Pre-Operative, Week 12 & Week 24 This provides a performance-based measure of physical function. As participants walk a 10-metre walkway at their usual and fast pace.
- Secondary Outcome Measures
Name Time Method 30 seconds-sit-to-stand test: Pre-Operative, Week 12 & Week 24 A test to assess participants' ability to rise from a chair and return to the sitting position within 30seconds from standard chair (43-47cm) without the use of their hands will be recorded.
Knee range-of-motion: Pre-Operative, Week 12 & Week 24 A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.
Knee pain: Pre-Operative, Week 12 & Week 24 Knee pain intensity while navigating stairs, walking, standing and performing a sit-to-stand will be measured using the 10-point numeric pain rating scales (NPRS).
0 - No pain 10 - Extremely painful5-repetition-sit-to-stand test: Pre-Operative, Week 12 & Week 24 A test to assess participants' ability to rise from a chair and return to the sitting position. The time taken for participant to stand up and sit down five times as fast as possible from standard chair (43-47cm) without the use of their hands will be recorded. This test is a measure that is performed as part of standard clinical practice and is also a measure of lower limb strength and dynamic balance.
Physical function: Pre-Operative, Week 12 & Week 24 The physical function will be measured using the subscale of Knee Osteoarthritis Outcome Score (KOOS) and Global Rating Scale, which are designed to evaluate the patient's opinion about their knee and associated problem.
Muscle strength: Pre-Operative, Week 12 & Week 24 One-repetition Maximum(1RM) is a measure of the maximal weight a participant can lift with one repetition.
Stair climb test: Pre-Operative, Week 12 & Week 24 This assesses the participants' ability to ascend and descend stairs, their lower limb strength, balance and endurance. The timing required for participants to ascend one flight of stairs, turn around and descend the same flight of stairs will be taken. The stair climb test is a measure that is performed as part of standard clinical practice.