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

NCT ID: NCT07239258

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mir Shakeel Teleintegrated Therapy plan

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mir Shakeel Ahmad

OTHER

Sponsor Role: lead

Responsible Party

Mir Shakeel Ahmad

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr. Mir Shakeel Ahmad, PhD Scholar

Role: PRINCIPAL_INVESTIGATOR

Ghurki Trust and Teaching Hospital

Locations

Ghurki Trust and Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

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

Role: CONTACT

mirshakeel.phdscholar@lincoln.edu.my

00923224268894

Salwa Atta Dr. Salwa Atta, PhD Scholar, MSPT

Role: CONTACT

salwa.atta@ubas.edu.pk

00923084579229

Facility Contacts

Dr. Mir Shakeel Ahmad Dr. Mir Shakeel Ahmad, PhD Scholar, MSPT

Role: primary

mir.ahmad@ghurkitrust.org.pk

00923224268894

Dr. Naeem Ahmad Prof. Dr. Naeem Ahmad

Role: backup

naeem.ahmad@ghurkitrust.org.pk

Other Identifiers

PHDMSTITPLUCGTTH24

Identifier Type: -

Identifier Source: org_study_id