Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation
Condition: Total Knee Replacement
Study type: Interventional

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.
    

Detailed description: 
      Study Hypotheses

      Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of
      functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3
      and at 6 months after total knee replacement (TKR) in improving physical function (fast gait
      speed).

      Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring
      of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3
      and at 6 months after TKR in improving knee pain, physical impairments, and health-related
      quality of life.

      Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more
      cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs

      Approach and Methods

      This will be an assessor-blinded, parallel design, non-inferiority randomised controlled
      trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee
      replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority
      randomized controlled trials. Post TKR, all participants will undergo daily inpatient
      rehabilitation. At discharge, they will be given a standard booklet with advice on ice
      therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and
      participants will be randomised to receive either the telemonitored home exercise program or
      the hospital-based rehabilitation program.
    

Intervention name(s): Tele-monitored home exercise program; Hospital-based rehabilitation program
Intervention type(s): Device; Other
Intervention description(s): Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment