Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: Tele-monitored home exercise program
* Other: Hospital-based rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hospital-based rehabilitation program<br> | Other: Hospital-based rehabilitation program<br>* 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.<br>|
| Experimental: Tele-monitored home exercise program<br> | Device: Tele-monitored home exercise program<br>* Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | The physical function subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) is designed to evaluate the patient's opinion about their physical function. All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for the subscale. | Pre-operation; 3 months and 6 months post-surgery | 
| Quadriceps muscle strength | Maximum voluntary isometric torque of the quadriceps muscles (at 70 degrees knee flexion) will be measured using a Biodex dynamometer | Pre-operation; 3 months and 6 months post-surgery | 
| 30s chair stand test | Total number of sit-to-stand repetitions completed in 30 seconds will be recorded. This is a measure of lower limb strength and endurance. | Pre-operation; 3 months and 6 months post-surgery | 
| Knee Pain: Numeric Pain Rating Scale (NPRS) | Knee pain intensity during climbing stairs, walking, and sitting-to-standing will be measured using separate 11-point numeric pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain. | Pre-operation; 3 months and 6 months post-surgery | 
| Knee range-of-motion | A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position. | Pre-operation; 3 months and 6 months post-surgery | 
| EuroQol-5 Dimensions (EQ-5D-5L) descriptive system | The EuroQol-5 Dimensions (EQ-5D-5L) is a standardised instrument to measure health related quality of life in cost-effectiveness analysis. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patients' decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | Pre-operation; 3 months and 6 months post-surgery | 
| Cost | Cost questionnaire measuring the direct and indirect costs. | 3 months and 6 months post-surgery | 
| Treatment satisfaction: scale | Participants will rate their satisfaction with treatment on a 11 point likert scale, with 0 indicating no satisfaction and 10 indicating complete satisfaction. | 3 months post-surgery | 
| Treatment credibility | To assess participants' confidence about the benefits of the intervention. Participants will rate their satisfaction with treatment on a 11 point likert scale, with 0 indicating not confident and 10 indicating extremely confident. | 3 months post-surgery | 
| STarT Back Screening Tool | The psychological subscale of the STarT Back Screening Tool will be determined by summing all items related to fear, anxiety, catastrophizing, depression, and bothersomeness. The STarT Back Screening Tool will be modified for use in the total knee replacement population by replacing the word back with knee. | Pre-operation; 3 months and 6 months post-surgery | 
| Örebro Musculoskeletal Pain Screening Questionnaire (short form) | This 10 item questionnaire evaluates psychological factors that potentially influence pain and/or function. These items are scored 0-10, where 0 refers to absence of impairment and 10 to severe impairment. Three items need to be reversed in order for all the questions to be oriented in the same direction. The total score will range between 1 and 100. A score above 50 indicates higher estimated risk for future work disability. | Pre-operation; 3 months and 6 months post-surgery |