Knee OsteoarthritisNCT06101355
Effectiveness of Telerehabilitation in Total Knee Arthroplasty
A study testing Telerehabilitation and Standard Home Based Exercise Group in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Telerehabilitation and Standard Home Based Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Telerehabilitation, Standard Home Based Exercise Group
- Keywords
- Total Knee Arthroplasty, Telerehabilitation, Home Exercise, Osteoarthritis, Orthopaedic Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
Standard Home Based Exercise GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group Based on Home Exercises | Experimental | Intervention group is home exercise program supplemented with visual and video resources using telerehabilitation. Receives: Other: Telerehabilitation |
| Standard Home Exercise Group | Active comparator | Standard home based exercise group Receives: Other: Standard Home Based Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion Range of Motion of the Knee
Assessment of active and passive flexion range of motion of both knee with digital goniometer
Measured: Postoperatively first day, fourth week and eight week
Secondary outcomes (11)
Demographic Data
The demographic data such as gender,age, body weight and height, comorbidities of the individuals included the study will be recorded
Measured: Postoperatively first day
Mental State
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.
Measured: Postoperatively first day
Range of Motion
Assessment of range of motion of the knee including active and passive flexion and extension by digital goniometer
Measured: Postoperatively first day, fourth week and eight week
Assessment of Pain
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.
Measured: Postoperatively first day, fourth week and eight week
Assessment of Kinesiophobia
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
Measured: Postoperatively first day, fourth week and eight week
Assessment of Artificial Joint Awareness
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
Measured: Postoperatively fourth week and eight week
Assessment of Pain, Stiffness and Physical Function
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.
Measured: Postoperatively first day, fourth week and eight week
Assessment of Patient Adherence
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.
Measured: Postoperatively fourth week and eight week
Assessment of Function
5 Times Sit to Stand Test
Measured: Postoperatively first day, fourth week and eight week
Assessment of Telemedicine Satisfaction and Usefulness
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.
Measured: Postoperatively fourth week and eight week
Assessment of Quadriceps Muscle Strength
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.
Measured: Postoperatively fourth week and eight week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Medipol University
- Responsible party
- Principal investigator, Sema Nur Aslan, Hacettepe University
- Investigators
- Sema Nur Aslan, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101355
- Sponsor's protocol ID
- Telerehabilitation
- Status last verified
- Apr 2025
- First submitted
- 20 Oct 2023
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Telerehabilitation in Individuals With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06101355
- Acronym / sponsor ID
- Telerehabilitation
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Telerehabilitation, Home Exercise, Osteoarthritis, Orthopaedic Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara Medipol University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group Based on Home Exercises | Experimental | Other: TelerehabilitationIntervention group is home exercise program supplemented with visual and video resources using telerehabilitation. |
| Standard Home Exercise Group | Active comparator | Other: Standard Home Based Exercise GroupStandard home based exercise group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationIntervention 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. | Other | Telerehabilitation Group Based on Home Exercises |
| Standard Home Based Exercise GroupControl 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. | Other | Standard Home Exercise Group |
Primary outcome
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
11 secondary outcomes
Demographic Data
Time frame: Postoperatively first day
Mental State
Time frame: Postoperatively first day
Range of Motion
Time frame: Postoperatively first day, fourth week and eight week
Assessment of Pain
Time frame: Postoperatively first day, fourth week and eight week
Assessment of Kinesiophobia
Time frame: Postoperatively first day, fourth week and eight week
Assessment of Artificial Joint Awareness
Time frame: 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 Patient Adherence
Time frame: Postoperatively fourth week and eight week
Assessment of Function
Time frame: Postoperatively first day, fourth week and eight week
Assessment of Telemedicine Satisfaction and Usefulness
Time frame: Postoperatively fourth week and eight week
Assessment of Quadriceps Muscle Strength
Time frame: Postoperatively fourth week and eight week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sema Nur Aslan principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Standard Home Based Exercise Group in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 2 May 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flexion Range of Motion of the Knee (time frame: Postoperatively first day, fourth week and eight week). 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 2 May 2025.