- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06457620
Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
June 10, 2024 updated by: Muhammad Naveed Babur, Superior University
This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective is to assess whether telerehabilitation can provide comparable or significantly better outcomes in terms of functional recovery, pain management, improved range of motion, and patient satisfaction for Total Knee Replacement (TKR) patients.
If telehealth interventions prove successful, they can be implemented to increase access to high-quality rehabilitation treatments and enhance healthcare delivery.
Evidence-based findings from this study can help healthcare providers make educated decisions about incorporating telerehabilitation into post-operative rehabilitation protocols, thereby enhancing patient care and optimizing resource utilization in orthopedic settings.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Acti Life Physiotherapy and Rehabilitation Center Horizon Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male and female patients diagnosed with TKR
- Older Age above 65
- Patient communicates with medical staff
- Patient with cemented TKA
- Patients who underwent TKA owing to degenerative arthritis
Exclusion Criteria:
- Older patients aged >75 years
- Patient with a history of knee joint surgery before TKA
- Patient who possibly had a systematic inflammatory disease such as rheumatoid arthritis.
- Patients with difficulty in seeing, hearing, and walking independently
- Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
- Patient history of severe mobility disorder
- Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: conventional physiotherapy
|
Each participant received conventional physiotherapy at the clinic as a part of their management plan.
Group A exercise was five times a week for thirty minutes, beginning on the third day after total knee arthroplasty (TKA).
The program aimed to improve leg strength, core stability, balance, and overall performance through exercise instructions.
The baseline evaluation was completed one day before the TKA, and the posttest was completed four weeks after the TKA.
|
Other: traditional physical treatment
|
Each participant got traditional physical treatment during a video conference as part of telerehabilitation.
The physiotherapy assistant contacted Group B to arrange a virtual follow-up clinic appointment via Zoom or WhatsApp, along with a 4-week program.
We inquired about the patient's level of satisfaction with their TKR procedure.
The patient was informed that clinical photos were taken, and the video call was to be recorded.
Before the virtual clinic, each patient's verbal agreement was acquired.
With workout instructions, the program pursued to enhance leg strength, core stability, balance, and overall performance.
The posttest was conducted four weeks after the TKA, and the baseline assessment was finished one day before the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario and McMaster Universities Osteoarthritis (WoMAC)
Time Frame: 12 Months
|
The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions).
The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points.
,
|
12 Months
|
Knee Outcome Survey-Activities of Daily Living (KOS-ADLS)
Time Frame: 12 months
|
The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living subscale) or sports (sports activity subscale).
The lower the percentage, the higher the disability.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
May 1, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
June 10, 2024
First Submitted That Met QC Criteria
June 10, 2024
First Posted (Actual)
June 13, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 10, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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