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

NCT07239258 | Recruiting

• 1 other identifier: PHDMSTITPLUCGTTH24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to determine the effects of a newly formed treatment protocol implemented as telerehabilitation and compare it with conventional physical therapy in patient recovery after Total Knee Arthroplasty. The main questions this study aims to answer are: Does telerehabilitation improve pain, range of motion, and gait as effectively as conventional physical therapy? Does telerehabilitation enhance exercise adherence, reduce kinesiophobia, and improve quality of life and patient satisfaction? Can a hybrid rehabilitation protocol combining both approaches optimize clinical and functional outcomes? Researcher will compare telerehabilitation-based physical therapy with traditional in-person therapy to see which method provides superior results in post-TKA recovery. Participants Will: Be adults aged 50-65 years who have undergone primary total knee arthroplasty Receive either conventional physical therapy or a telerehabilitation-based exercise plan for a defined intervention period Attend scheduled follow-up assessments to measure pain, range of motion, gait, functional performance, and satisfaction Complete validated questionnaires on quality of life, kinesiophobia, and exercise adherence Study Significance Osteoarthritis is a growing health concern in Pakistan, with prevalence rising from 2.85 million in 1990 to 8.49 million in 2021. The increasing number of TKA procedures has created a demand for accessible, cost-effective, and evidence-based rehabilitation models. Telerehabilitation offers an innovative solution by extending professional care to patients' homes, enhancing accessibility, and ensuring continuity of therapy. This study will provide locally relevant evidence and may lead to the development of a standardized rehabilitation protocol for Pakistani patients - improving recovery outcomes, reducing healthcare burden, and enhancing post-surgical quality of life Ultimately, this research seeks to strengthen evidence-based rehabilitation in Pakistan, reduce the post-surgical burden of disability, and enhance the quality of life for individuals recovering from knee arthroplasty. This RCT is based on a comparison of 2 groups. One will receive the MSTITP and other group will receive in person conventional physical therapy plan. This is based on 2 arm testing and the hypothesis is that the MSTITP is more effective in improving patient related outcomes in patients undergoing Total Knee Arthroplasty. Participants in group A will perform a specific set of exercises ( details can be provided as and when asked) in a mode as convenient for the patients. The effect of Telerehabilitation will also be evaluated. Participants in Group B will receive Conventional Physical Therapt as documented in in person sessions and will be followed for the same duration as of Patients in Group A.

Conditions

Total Knee Anthroplasty; Total Knee Arthroplasty Recovery

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

  SF 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 WOMAC 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' OGA

  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 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.

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

• Mir Shakeel Ahmad: 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, PhD Scholar

  Ghurki Trust and Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Mir Shakeel Ahmad, PhD Scholar, MS-PT, T-DPT

CONTACT

00923224268894; mirshakeel.phdscholar@lincoln.edu.my

Salwa Atta Dr. Salwa Atta, PhD Scholar, MSPT

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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

PA (1)