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Total Knee AnthroplastyRCTNCT07239258

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

A study testing Mir Shakeel Teleintegrated Therapy plan and Conventional Physical Therapy in people with Total Knee Anthroplasty and Total Knee Arthroplasty Recovery, run by Lincoln University College Malaysia at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 65 years
What is being tested?
Mir Shakeel Teleintegrated Therapy plan and Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePakistan
Study dates
30 Nov 2025to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site, 1 recruiting
  • Ghurki Trust and Teaching Hospital

    Lahore, Punjab Province

    Dr. Mir Shakeel Ahmad, 00923224268894, mir.ahmad@ghurkitrust.org.pk

    Prof. Dr. Naeem Ahmad, naeem.ahmad@ghurkitrust.org.pk

    Recruiting

Other trials in Pakistan

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Mir Shakeel Teleintegrated Therapy plan, Conventional Physical Therapy
Keywords
pain, range of motion, gait, functional outcomes, quality of life, conventional physical therapy, total knee arthroplasty
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mir Shakeel Teleintegrated Therapy planOther

    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 TherapyOther

    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.

Study groups in NCT07239258
Study groupRoleWhat they receive
MSTITP GroupExperimentalThe 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.
Receives: Other: Mir Shakeel Teleintegrated Therapy plan
Conventional Physical TherapyActive comparatorThe 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.
Receives: Other: Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of Motion

    Range of motion shall be measured through Goniometry

    Measured: WEEK 1- WEEK 12

  2. 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.

    Measured: Week 1 - Week 12

  3. 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.

    Measured: WEEK 1-WEEK 12

  4. 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

    Measured: Week 1- Week 12

  5. 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.

    Measured: WEEK 1 - WEEK 12

Secondary outcomes (2)
  1. Patient Satisfaction as assessed through Patient Satisfaction Questionnaire

    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.

    Measured: WEEK 1- WEEK 12

  2. Exercise Adherence as assessed through Exercise Adherence Rating Scale

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

    Measured: Week 1 - week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start30 Nov 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07239258
Sponsor's protocol ID
PHDMSTITPLUCGTTH24
Acronym
RCT
Status last verified
Jul 2026
First submitted
15 Nov 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mir Shakeel Teleintegrated Therapy plan and Conventional Physical Therapy in people with Total Knee Anthroplasty and Total Knee Arthroplasty Recovery, run by Lincoln University College Malaysia at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Mir Shakeel Ahmad (00923224268894, mirshakeel.phdscholar@lincoln.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of Motion (time frame: WEEK 1- WEEK 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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