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NCT Number: NCT07239258

The Effects of Mir Shakeel Teleintegrated Therapy Plan 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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mir Shakeel Teleintegrated Therapy plan

Other

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.

Conventional physical therapy

Other

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 outcomes

  1. Range of Motion

    Time frame: WEEK 1- WEEK 12

    Range of motion shall be measured through Goniometry

  2. Pain of patient as assessed by Numerical Pain Rating Scale

    Time frame: Week 1 - Week 12

    The scale is composed of a scoring of 1 to 10 where 1 shows minimal pain and 10 shows maximal.

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

    Time frame: WEEK 1-WEEK 12

    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.

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

    Time frame: Week 1- Week 12

    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

  5. Gait as assessed through Jack's Observatory Gait Analysis

    Time frame: WEEK 1 - WEEK 12

    Gait analysis shall be done through Jacks' Observatory Gait Analysis. Temporal Parameters like Step length, Stride length, Cadence and Symmetry will be assessed.

Secondary outcomes

  1. Patient Satisfaction as assessed through Patient Satisfaction Questionnaire

    Time frame: WEEK 1- WEEK 12

    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.

  2. Exercise Adherence as assessed through Exercise Adherence Rating Scale

    Time frame: Week 1 - week 12

    Exercise adherence rating scale will be used to measure exercise adherence and the score ranges from 0-24. Higher scores reflect better exercise adherence.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Mir Shakeel Ahmad

CONTACT

[email protected]

00923224268894

Dr. Salwa Atta

CONTACT

[email protected]

00923084579229

Sponsors and collaborators

Lead sponsor

Lincoln University College Malaysia

Other

Registry information

Official study 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

Acronym: RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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