The Effects of Mir Shakeel Teleintegrated Therapy Plan in Patients Undergoing Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorLincoln University College Malaysia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mir Shakeel Teleintegrated Therapy plan
Other interventionThis intervention plan encompasses a weekly based exercise plan initated right from the Indoor patient department post surgery till week 23. It begins from within 24 hours of surgery and extends till 12 weeks post surgery. This includes sets of exercises in which the plan of week 1 includes patient education, bed mobility, transfers, ankle pumps, heel slides, straight reg raises, supine hip abduction and adduction, quads sets and seated knee flexion. Week 2 -4 include cryotherapy, ankle pumps, quad sets, heel slides, mini squats, standing heel raises, seated knee flexion and extension, marching in place and step ups. Week 4-6 include step ups, tandem walking, 3-d straight leg raises, sit to stand, single leg balance, mini squats, lunges, standing heel raises, marching with walker and toe raises while standing. Week 6-12 include single leg balance, gait training, single leg stand with trunk rotation, basu ball training, sideway walk and squats. This is encompassed by TR as \&when needed.
Conventional Physical Therapy
Other interventionThe Group B shall receive the same exercise plan in in - person treatment sessions 2-3 times per week. The set of exercises and frequency incorporated match with the one being provided to patients in group CPT.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: MSTITP GroupExperimental treatment 1 intervention
Group B: Conventional Physical TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Range of Motion
Range of motion shall be measured through Goniometry
Time frame
WEEK 1- WEEK 122
Pain of patient as assessed by Numerical Pain Rating Scale
The scale is composed of a scoring of 1 to 10 where 1 shows minimal pain and 10 shows maximal.
Time frame
Week 1 - Week 123
Quality of Life as assessed by Short Form Health Survey -36
Short Form 36 evaluates patient functions in 8 domains including physical functions, role limitations, body pain, health perceptions, vitality, social functions, role limitations and mental health. Higher schores reflect more functional impairements and lesser scores show less impairements. Each item is evaluated on a scale of 0-100.
Time frame
WEEK 1-WEEK 124
Functional outcomes as assessed by Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster University Osteoarthritis Index is composed of 24 questions and scores from 0 to 96 where 0 reflects best health status
Time frame
Week 1- Week 12Secondary outcomes
1
Patient Satisfaction as assessed through Patient Satisfaction Questionnaire
Patient Satisfaction shall be evaluated through Patient Satisfaction Questionnaire -18 and it contains 18 items. Each item is scored from 1 to 5 and maximum score is 90 with 90 reflecting the best satisfaction levels of patients.
Time frame
WEEK 1- WEEK 122
Exercise Adherence as assessed through Exercise Adherence Rating Scale
Exercise adherence rating scale will be used to measure exercise adherence and the score ranges from 0-24. Higher scores reflect better exercise adherence.
Time frame
Week 1 - week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lincoln University College Malaysia
Lead sponsor
Ghurki Trust and Teaching Hospital
Sponsor institution
Source ClinicalTrials.gov