Clinical trial NCT06248034: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Keywords: Knee Arthroplasty;
Orthopedic Procedures;
Outcome Assessments;
Self- Help Devices;
Technology;
Knee: Treatment Outcome
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Rootally AI PTE LTD
First posted: 2024-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will perform stratified randomization by surgeons, are evenly distributed between the 2 treatment arms. Arm 1: Smartphone Home-based Rehabilitation Program (N=15); Arm 2: Hospital-based rehabilitation program (N=15).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait speed:
timeFrame: Pre-Operative, Week 12 & Week 24
Secondary outcomes:
measure: Physical function:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: Muscle strength:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: Knee pain:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: Knee range-of-motion:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: Stair climb test:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: 5-repetition-sit-to-stand test:
timeFrame: Pre-Operative, Week 12 & Week 24
measure: 30 seconds-sit-to-stand test:
timeFrame: Pre-Operative, Week 12 & Week 24
Other outcomes:
measure: Quality of the mobile application:
timeFrame: Week 12 & Week 24
measure: Treatment credibility:
timeFrame: Week 24
measure: Perceived usefulness and ease of use:
timeFrame: Week 12 & Week 24
measure: Participants satisfaction:
timeFrame: Week 12 & Week 24
measure: EQ5D-5L:
timeFrame: Week 12 & Week 24
measure: Adverse effects:
timeFrame: Week 24
measure: Implementation outcomes:
timeFrame: Week 12 & Week 24
Locations:
Study officials:
References: