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

Official title

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

Overview

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.

Detailed description

This study is a two-arm, parallel-group randomized clinical 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.

Interventions

• 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, q
• Other Conventional Physical Therapy
  The 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.

Primary outcome measures

• Range of Motion [Time frame: WEEK 1- WEEK 12]
• Pain of patient as assessed by Numerical Pain Rating Scale [Time frame: Week 1 - Week 12]
• Quality of Life as assessed by Short Form Health Survey -36 [Time frame: WEEK 1-WEEK 12]
• Functional outcomes as assessed by Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: Week 1- Week 12]
• Gait as assessed through Jack's Observatory Gait Analysis [Time frame: WEEK 1 - WEEK 12]

Secondary outcome measures (2)

• Patient Satisfaction as assessed through Patient Satisfaction Questionnaire [Time frame: WEEK 1- WEEK 12]
• Exercise Adherence as assessed through Exercise Adherence Rating Scale [Time frame: Week 1 - week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Ghurki Trust and Teaching Hospital — Lahore

Identifiers

NCT: NCT07239258 · PHDMSTITPLUCGTTH24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗