Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement

Study Overview
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Brief Summary
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Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. There is a need to develop innovative rehabilitation strategies that (i) provide patients with accurate cues allowing for better compliance and exercise performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and identify deviation from recovery trajectories post-discharge, prior to their first outpatient appointment, and (iii) reduce reliance on manpower and variability during rehabilitation sessions. Technological solutions that empower patients and allow home-based rehabilitation to take place without the need for real-time human supervision could be the key to improving effectiveness and lowering costs. A mobile application which detects key landmarks on the body for human pose estimation will allow patients to perform their rehabilitation exercises with real-time feedback allowing for proper execution of the exercises. Physiotherapists will be able to access the data generated from the exercise session via a command centre to monitor patients' recovery progress and compliance. The primary aim of this pilot study is to evaluate the feasibility of using a mobile application during rehabilitation in patients after a TKR surgery. The secondary aim is to study the effects of using a mobile application during rehabilitation on knee functional status, exercise self-efficacy, and treatment satisfaction after TKR surgery.

Official Title
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Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement: A Pilot Feasibility Randomized Controlled Trial

Conditions
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Total Knee Replacement, Total Knee Arthroplasty

Intervention / Treatment
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* Device: Mobile application
* Other: Standard rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary unilateral total knee replacement Age >= 45 years Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1) Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group Ability to provide informed consent Is technologically savvy - at least 6 months' experience using a smartphone and able to key in data into a smartphone English-speaking Exclusion Criteria: 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 or intention to continue outpatient physiotherapy service at another institution Unable to perform 5 repetitions of inner-range quadriceps exercise

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 100 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: Standard rehabilitation program<br> | Other: Standard rehabilitation program<br>* All participants will be seen by physiotherapists in the ward post-TKR surgery and undergo standard inpatient rehabilitation. Patients will be given instructions to perform assigned exercises 3 times daily. Physiotherapists will perform the required assessment/review, education, and intervention.<br>|
| Experimental: Mobile application<br> | Device: Mobile application<br>* Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned exercises using the mobile application 3 times daily. Physiotherapists will still perform the required assessment/review, education, and intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Frequency of exercise sessions completed | 6 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee range-of-motion | A long-arm goniometer will be used to measure knee flexion and extension range-of-motion. | Pre-operation; 6 weeks post-surgery | 
| Gait speed | Usual and fast gait speed | Pre-operation; 6 weeks post-surgery | 
| Knee Pain | Knee 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; 6 weeks post-surgery | 
| 30 second sit to stand | 30 second sit to stand test | Pre-operation; 6 weeks post-surgery | 
| Self-report physical function | All items are scored on 5-point Likert scales. With100 indicating no symptoms and 0 indicating extreme symptoms. | Pre-operation; 6 weeks post-surgery | 
| Self-efficacy | Self-efficacy questionnaire | Pre-operation; 6 weeks post-surgery | 
| Total contact time | Time spent with the patients | 6 weeks post-surgery | 
| Quality of the mobile application | Quality of the mobile application questionnaire. All items are scored on 5-point Likert scales with 1 indicating Inadequate and 5 indicating Excellent. | 6 weeks post-surgery | 
| Participant satisfaction | Participants will rate their satisfaction with treatment on an 11-point Likert scale, with 0 indicating no satisfaction and 10 indicating complete satisfaction. | 6 weeks post-surgery | 
| Treatment credibility | Participants will rate their confidence about the benefits of the intervention on an 11-point Likert scale, with 0 indicating not confident and 10 indicating extremely confident. | 6 weeks post-surgery | 
| Perceived usefulness and ease of use | Participants will rate their perceived usefulness and ease of use of the intervention on an 11-point Likert scale, with 0 indicating not useful or not easy and 10 indicating extremely useful or extremely easy. | 6 weeks post-surgery |