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

NCT07239258 | Recruiting

• 1 other identifier: PHDMSTITPLUCGTTH24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty Recovery; Total Knee Anthroplasty

Keywords

pain; range of motion; gait; functional outcomes; quality of life; conventional physical therapy; total knee arthroplasty

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Patient Satisfaction as assessed through Patient Satisfaction Questionnaire

  WEEK 1- WEEK 12

• Exercise Adherence as assessed through Exercise Adherence Rating Scale

  Week 1 - week 12

Study Arms (2)

MSTITP Group

EXPERIMENTAL

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

Conventional Physical Therapy

ACTIVE COMPARATOR

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

Interventions

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.

MSTITP Group

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.

Conventional Physical Therapy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: Both males and females will be allwed to particpate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lincoln University College Malaysia: lead

Study Sites (1)

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Mir Shakeel Ahmad

  Lincoln College University

  PRINCIPAL INVESTIGATOR

• Prof Dr. Chua Siew Kuan

  Lincoln College University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mir Shakeel Ahmad

CONTACT

00923224268894; mirshakeel.phdscholar@lincoln.edu.my

Dr. Salwa Atta

CONTACT

00923084579229; salwa.atta@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Indoor Patient Department Incharge

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)