Effectiveness of Telerehabilitation in Total Knee Arthroplasty

April 29, 2025 updated by: Sema Nur Aslan, Hacettepe University

Comparison of the Effectiveness of Telerehabilitation in Individuals With Total Knee Arthroplasty

In patients who have had joint replacement surgery, there is a shortage of concrete evidence regarding the effectiveness of telerehabilitation. The aim of this study is to compare telerehabilitation with home based exercise program and standard home exercise program in total knee arthroplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of our study is to assess the effectiveness of telerehabilitation in comparison to the conventional approach, specifically focusing on particular parameters, in the context of post-total knee arthroplasty surgery. This investigation will entail a comparative analysis between a home exercise program prescription supplemented with visual and video resources using telerehabilitation and the conventional home exercise program prescription.

The aim of our study is comparison between two exercise prescription modalities : a standard home exercise program and an internet-based program utilizing the Rehab My Patient software with visual and video support, in addition to telerehabilitation program, which involves exercise prescription oversight via video consultations. This comparison will include the following parameters : range of motion, proprioception , function, kinesiophobia, pain , patient adherence, patient satisfaction and Quadriceps muscle strength.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Hacettepe University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants aged 50 and over
  • Having a primary total knee arthroplasty surgery
  • To possess a device, such as a smartphone or tablet, that enables access to mobile applications.
  • To have the capability to use the internet and to have internet access.
  • Proficiency in reading and writing in the Turkish language
  • Having a Mini-Mental State Examination(MMSE) score of 24 or higher
  • To be willing to participate in the study

Exclusion Criteria:

  • Having cognitive problem
  • Having a secondary total knee arthroplasty surgery
  • Havig a revision surgery
  • Having a history of cerebrovascular and/or cardiovascular events in the last 3 months
  • Having uncontrolled diabetes and/or hypertension
  • Having a arthrogenic muscle inhibition

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telerehabilitation Group Based on Home Exercises
Intervention group is home exercise program supplemented with visual and video resources using telerehabilitation.
Other: Telerehabilitation

Intervention group is home exercise program supplemented with visual and video resources using telerehabilitation. With the exercises, there will be video links, exercise visuals, and written explanations. Videos and visuals of the exercises recorded by the physiotherapist and uploaded to the Rehab My Patient application.

Digital exercise forms will be prepared through the Rehab My Patient application. The intervention group will receive exercises, which prepared from the Rehab My Patient application ,digitally through WhatsApp. In this group, exercise sessions will be conducted with the physiotherapist once a week through video calls. Additionally, there will be one instance of messaging and one phone call for follow-up. Video calls and messaging will be conducted through WhatsApp.
Active Comparator: Standard Home Exercise Group
Standard home based exercise group
Other: Standard Home Based Exercise Group
Control group, standard home exercise program group , will receive the program as brochures. Although there will be no video supplement, the brochure will include visuals of the exercises. The control group will be monitored through three weekly voice calls.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flexion Range of Motion of the Knee
Time Frame: Postoperatively first day, fourth week and eight week
Assessment of active and passive flexion range of motion of both knee with digital goniometer
Postoperatively first day, fourth week and eight week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic Data
Time Frame: Postoperatively first day
The demographic data such as gender,age, body weight and height, comorbidities of the individuals included the study will be recorded
Postoperatively first day
Mental State
Time Frame: Postoperatively first day
Mini Mental State Examination consists of 30 questions.The test results range from 0 to 30 points. A score of 0-10 points indicates severe impairment, 10-20 points suggests moderate impairment, 20-25 points indicate mild impairment, and a score of 25-30 points is considered normal.
Postoperatively first day
Range of Motion
Time Frame: Postoperatively first day, fourth week and eight week
Assessment of range of motion of the knee including active and passive flexion and extension by digital goniometer
Postoperatively first day, fourth week and eight week
Assessment of Pain
Time Frame: Postoperatively first day, fourth week and eight week
Assessment the pain while rest, night and activity by using Visual Analog Scale which is a 100 mm line drawn laterally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values.
Postoperatively first day, fourth week and eight week
Assessment of Kinesiophobia
Time Frame: Postoperatively first day, fourth week and eight week
Assessment of kinesiophobia via Brief Fear of Movement. This scale consists of 6 items, which are items 1, 2, 9, 10, 14, and 15 from the Tampa Scale for kinesiophobia. It is a valid approach for assessing movement fear in patients with osteoarthritis
Postoperatively first day, fourth week and eight week
Assessment of Artificial Joint Awareness
Time Frame: Postoperatively fourth week and eight week
Assessment of artificial joint awareness via Forgotten Joint Score-12. This scale consists of 12 items.Item 12 of the scale has not been considered suitable for use in the Turkish population. High scores reflect the degree to which one can forget and adapt to the side of the surgery, typically represented as a percentage
Postoperatively fourth week and eight week
Assessment of Pain, Stiffness and Physical Function
Time Frame: Postoperatively first day, fourth week and eight week
Assessment of pain, stiffness and physical function via WOMAC(The Western Ontario and McMaster Universities). 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. Higher scores indicates higher disability.
Postoperatively first day, fourth week and eight week
Assessment of Patient Adherence
Time Frame: Postoperatively fourth week and eight week
Assessment of patient adherence via The Exercise Adherence Rating Scale. The scale consists of three sections: Part A, Part B, and Part C. Part A and Part B each consist of 6 questions, while Part C comprises 10 items.The total score ranges from 0 to 64. A high score indicates better adherence to exercise or a higher level of exercise compliance.
Postoperatively fourth week and eight week
Assessment of Function
Time Frame: Postoperatively first day, fourth week and eight week
5 Times Sit to Stand Test
Postoperatively first day, fourth week and eight week
Assessment of Telemedicine Satisfaction and Usefulness
Time Frame: Postoperatively fourth week and eight week
Assessment of Telemedicine Satisfaction and Usefulness via Telemedicine Satisfaction and Usefulness Questionnaire(TSUQ). TSUQ consists of 21 items.This questionnaire assesses the satisfaction levels and usability of telemedicine services among individuals. The total score range from 21 to 105.
Postoperatively fourth week and eight week
Assessment of Quadriceps Muscle Strength
Time Frame: Postoperatively fourth week and eight week
Assessment of Quadriceps Muscle Strength via Lafayette Manual Muscle Tester.The Lafayette Manual Muscle Tester is used for the objective evaluation of muscle strength. It has both intra-rater and inter-rater reliability and is an ideal tool for tracking progress throughout the rehabilitation process.
Postoperatively fourth week and eight week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sema Nur Aslan, Hacettepe University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Telerehabilitation

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings