RecruitingNot Applicable

The Effects of Mir Shakeel Teleintegrated Therapy Plan in Patients Undergoing Total Knee Arthroplasty

Pakistan120 participantsStarted 2025-06-26

Plain-language summary

This randomized controlled trial aims to evaluate the effectiveness of a newly developed Modified Structured Telerehabilitation Intervention Protocol (MSTITP) compared with conventional in-person physical therapy in patients recovering from Total Knee Arthroplasty (TKA). The study also explores whether a hybrid rehabilitation approach may further optimize patient outcomes. A total of eligible participants aged 50-65 years who have undergone primary TKA will be randomly assigned to one of two groups: Group A (Intervention): Telerehabilitation-based structured exercise program (MSTITP) delivered through digital platforms with remote supervision. Group B (Control): Standard conventional face-to-face physiotherapy in a clinical setting. Both groups will receive rehabilitation programs of equal duration focusing on pain management, range of motion (ROM), muscle strengthening, gait training, and functional mobility. The primary objective is to compare the effectiveness of telerehabilitation and conventional therapy in improving pain, ROM, and gait performance. Secondary objectives include evaluation of exercise adherence, kinesiophobia, functional outcomes, quality of life, and patient satisfaction. Additionally, the study will explore whether integrating telerehabilitation with conventional rehabilitation could provide superior outcomes. Outcome assessments will be conducted using validated tools including pain scales (VAS), goniometric ROM measurements, gait analysis, functional performance tests, and standardized questionnaires for quality of life, exercise adherence, and fear of movement. This study addresses the increasing burden of osteoarthritis and the growing number of TKA procedures in Pakistan. Telerehabilitation may offer a cost-effective, accessible, and scalable rehabilitation model that ensures continuity of care and improved access to physiotherapy services, particularly in resource-limited settings. The findings of this trial are expected to provide evidence for developing standardized, technology-assisted rehabilitation protocols to improve post-TKA recovery outcomes and reduce healthcare burden.

Who can participate

Age range

50 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have underwent a primary unilateral total knee arthroplasty due to osteoarthritis * Able to participate in a rehabilitation program, either telerehabilitation or in-person, and demonstrate sufficient mobility with or without assistive devices (e.g., crutches, walker) as deemed appropriate for post-TKA therapy. * Participants must have reliable access to a smartphone, tablet, or computer with internet connectivity and the ability to engage in video calls. * Willing and able to provide informed consent, and to comply with all study protocols, including scheduled therapy sessions and follow-up assessments. Exclusion Criteria: * Presence of significant comorbidities or complications that could interfere with safe participation in rehabilitation, such as severe cardiovascular disease, or conditions causing significant immobility (e.g., severe osteoarthritis in other joints or Rheumatoid Arthritis. * Previous knee replacement or other significant knee surgeries on the same knee, as this may impact the standardization of rehabilitation outcomes. * Currently enrolled in another physical therapy or rehabilitation trial, or engaging in additional rehabilitation outside the study protocol. * Cognitive impairment or severe visual or hearing impairments that would prevent them from following therapy instructions or engaging with telerehabilitation technology. * Any other conditions or factors that, in the opinion of the investigators, could hinder com…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Range of Motion

Timeframe: WEEK 1- WEEK 12

Pain of patient as assessed by Numerical Pain Rating Scale

Timeframe: Week 1 - Week 12

Quality of Life as assessed by Short Form Health Survey -36

Timeframe: WEEK 1-WEEK 12

Functional outcomes as assessed by Western Ontario and McMaster Universities Osteoarthritis Index

Timeframe: Week 1- Week 12

Gait as assessed through Jack's Observatory Gait Analysis

Timeframe: WEEK 1 - WEEK 12

Trial details

NCT IDNCT07239258

SponsorLincoln University College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Dr. Mir Shakeel Ahmad

00923224268894 mirshakeel.phdscholar@lincoln.edu.my

View on ClinicalTrials.gov More Total Knee Anthroplasty trials