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

The Effects of Mir Shakeel Teleintegrated Therapy Plan and Conventional Physical Therapy on Pain, Range of Motion, Gait, Functional Outcomes and Quality of Life in Patients Undergoing Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Anthroplasty; Total Knee Arthroplasty Recovery
• Intervention / Treatment: Other: Mir Shakeel Teleintegrated Therapy plan; Other: Conventional Physical Therapy

Detailed Description

This study is a two-arm, parallel-group randomized controlled trial designed to compare the clinical effectiveness of a Modified Structured Telerehabilitation Intervention Protocol (MSTITP) with conventional in-person physical therapy in patients following Total Knee Arthroplasty (TKA). The study also investigates whether a digitally supported rehabilitation model can serve as an effective or superior alternative to traditional physiotherapy care.

Participants will be recruited from post-operative TKA patients who meet eligibility criteria and provide informed consent. Eligible participants will be adults aged 50-65 years who have undergone primary unilateral TKA and are medically stable for rehabilitation. Participants with neurological disorders, revision surgeries, or contraindications to exercise will be excluded.

Following enrollment, participants will be randomly allocated into two equal groups:

Group A - Telerehabilitation (MSTITP)

Participants will receive a structured, progressive rehabilitation program delivered remotely via telecommunication platforms. The intervention will include:

Supervised exercise sessions conducted through video-based guidance Home-based progressive strengthening exercises Range of motion training protocols Gait re-education strategies Functional task-oriented exercises Regular remote monitoring and feedback from a physiotherapist

The protocol is designed to enhance accessibility, improve adherence, and ensure continuity of care in a home-based environment while maintaining clinical oversight.

Group B - Conventional Physiotherapy

Participants will receive standard postoperative rehabilitation through direct, face-to-face sessions in a clinical setting. Treatment will include:

Therapist-supervised exercise therapy Manual guidance for ROM improvement Strengthening exercises Gait training Functional mobility training Both groups will receive rehabilitation over an equal intervention duration to ensure comparability.

Outcome Measures

Participants in both groups will be assessed at predefined follow-up intervals using validated outcome measures.

Primary Outcomes:

Pain intensity (Visual Analog Scale - VAS) Knee Range of Motion (goniometric measurement) Gait performance and functional ambulation

Secondary Outcomes:

Functional performance (standardized functional tests) Exercise adherence levels Kinesiophobia (fear of movement) Health-related quality of life Patient satisfaction with treatment

Data will be analyzed using appropriate statistical methods to compare within-group and between-group differences over time. Intention-to-treat analysis will be considered to handle dropouts and maintain methodological rigor.

Rationale and Clinical Importance

Osteoarthritis is a major and increasing public health concern in Pakistan, contributing to a rising number of total knee arthroplasty procedures. This has created a significant demand for effective, accessible, and cost-efficient postoperative rehabilitation strategies.

Telerehabilitation represents an emerging model that may overcome barriers such as geographic limitations, limited physiotherapy access, financial burden, and poor adherence to clinic-based rehabilitation. By enabling structured rehabilitation in home settings with professional supervision, it has the potential to improve continuity of care and functional recovery.

This trial is expected to generate context-specific evidence regarding the effectiveness of telerehabilitation in a Pakistani healthcare setting and may contribute to the development of standardized postoperative rehabilitation guidelines for TKA patients. The findings may also support integration of hybrid rehabilitation models into routine clinical physiotherapy practice, ultimately improving functional outcomes and reducing healthcare system burden.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Mir Shakeel Ahmad; Phone Number: 00923224268894; Email: mirshakeel.phdscholar@lincoln.edu.my
• Study Contact Backup: Name: Dr. Salwa Atta; Phone Number: 00923084579229; Email: salwa.atta@ubas.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Recruiting
      • Ghurki Trust and Teaching Hospital
      • Contact: Dr. Mir Shakeel Ahmad; Phone Number: 00923224268894; Email: mir.ahmad@ghurkitrust.org.pk
      • Contact: Prof. Dr. Naeem Ahmad; Email: naeem.ahmad@ghurkitrust.org.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 compliance with the study procedures or put the participant at undue risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSTITP Group; The patients of this group will be treated by the Physical Therapist in person as well as at Telerehabilitation mode as and when convenient for the patients. The treatment which shall be provided is a personalized exercise based treatment protocol already tested through a pilot testing on 80 patients in the same setting. This protocol is set under the supervision of an expert Orthopedic Surgeon from Ghurki Trust and Teaching Hospital. The protocol is composed of a weekly based exercise plan for patients who have underwent Total Knee Arthroplasty. The frequency and duration of each exercise is set owing to the age, severity and duration of surgery.	Other: Mir Shakeel Teleintegrated Therapy plan; This 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.
Active Comparator: Conventional Physical Therapy; The patients of this group will receive conventional physical therapy in which patients will have all sessions in person and within the premises of hospital/clinic. All the exercises and protocol provided to patients of experimental group will be practiced by patients of group B but no shift of exercise mode to Telerehabilitation will be made in order to rule out the effects of telerehabilitation if any.	Other: Conventional Physical Therapy; The control group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Range of motion shall be measured through Goniometry	WEEK 1- WEEK 12
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.	Week 1 - Week 12
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.	WEEK 1-WEEK 12
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	Week 1- Week 12
Gait as assessed through Jack's Observatory Gait Analysis	Gait analysis shall be done through Jacks' Observatory Gait Analysis. Temporal Parameters like Step length, Stride length, Cadence and Symmetry will be assessed.	WEEK 1 - WEEK 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 1 - week 12
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.	WEEK 1- WEEK 12

Collaborators and Investigators

• Sponsor: Lincoln University College
• Collaborators: Lincoln University College Malaysia
• Investigators: Principal Investigator: Dr. Mir Shakeel Ahmad, Lincoln College University; Principal Investigator: Prof Dr. Chua Siew Kuan, Lincoln College University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pain; gait; quality of life; total knee arthroplasty; range of motion; functional outcomes; conventional physical therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: PHDMSTITPLUCGTTH24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No