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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Quality of Life as assessed by Short Form Health Survey -36
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional Physical Therapy (Other)
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.
干预措施: Mir Shakeel Teleintegrated Therapy plan (Other)
结局指标
主要结局
Quality of Life as assessed by Short Form Health Survey -36
时间窗: 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.
Functional outcomes as assessed by Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: 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
Gait as assessed through Jack's Observatory Gait Analysis
时间窗: 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.
Range of Motion
时间窗: WEEK 1- WEEK 12
Range of motion shall be measured through Goniometry
Pain of patient as assessed by Numerical Pain Rating Scale
时间窗: Week 1 - Week 12
The scale is composed of a scoring of 1 to 10 where 1 shows minimal pain and 10 shows maximal.
次要结局
- 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)
研究者
Mir Shakeel Ahmad
Principal Investigator; Indoor Patient Department Incharge
Ghurki Trust and Teaching Hospital