{
  "abstract": "Introduction Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.Methods and analysis Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.Ethics and dissemination The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.Trial registration number CTRI/2024/06/068838.",
  "authors": [
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Siaa Girotra"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Purnima Shrivastava"
    },
    {
      "affiliations": [
        "Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Ajit Kumar"
    },
    {
      "affiliations": [
        "Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Ruchika Madan"
    },
    {
      "affiliations": [
        "Department of Physiotherapy and Rehabilitation, Indraprastha Apollo Hospitals, New Delhi, India"
      ],
      "name": "Seema Grover"
    },
    {
      "affiliations": [
        "Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Sahil Batra"
    },
    {
      "affiliations": [
        "Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India"
      ],
      "name": "Bhavuk Garg"
    },
    {
      "affiliations": [
        "The George Institute for Global Health India, New Delhi, India",
        "The George Institute for Global Health, Sydney, New South Wales, Australia",
        "Prasanna School of Public Health, Manipal, India"
      ],
      "name": "Devarsetty Praveen"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Susmita Chatterjee"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Ankita Kasotia"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Shyamashree Biswas"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Manoj Soni"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India"
      ],
      "name": "Sridevi Gara"
    },
    {
      "affiliations": [
        "Department of Orthopedics, Indraprastha Apollo Hospitals, New Delhi, India"
      ],
      "name": "Rajesh Malhotra"
    },
    {
      "affiliations": [
        "Deakin University Institute for Physical Activity and Nutrition, Geelong, Victoria, Australia"
      ],
      "name": "Ralph Maddison"
    },
    {
      "affiliations": [
        "The George Institute for Global Health, New Delhi, India",
        "Prasanna School of Public Health, Manipal, India"
      ],
      "name": "Niveditha Devasenapathy"
    }
  ],
  "title": "How effective is mHealth-supported home-based post-knee arthroplasty rehabilitation in improving knee function and continuum of care: protocol of an open label randomised controlled trial from India",
  "uid": "18d8fdaa-171c-519c-b72f-6c40cdf3b008"
}