Knee OsteoarthritisKNEE_TelemonNCT06647446
Improvements in Function and Pain in the Rehabilitation of Patients With Knee Osteoarthritis Using an Exercise Program Telemonitored Compared to Conventional Treatment
A study testing Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
Osteoarthritis is a very prevalent pathology after the fifth decade of life. It usually appears in the hip and hand, although its presence in the knee is even greater, with a prevalence in subjects over 45 years of age of 19% radiographically (radiographic findings without taking symptoms into account) and 7% in the… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2024to 31 Dec 2025
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with osteoarthritis of the knee.
- Age >45 years.
- The patient presents with knee pain during physical activity.
- The patient reports knee symptoms in the last month.
- The patient has a mobile phone with internet access.
Who cannot join
- Previous knee surgeries.
- Planned surgeries during the duration of the trial.
- Patient is currently undergoing physical therapy.
- Patient currently has severe pathology that may compromise participation in the exercise program (advanced COPD, cardiac or arterial disease).
- Associated rheumatic pathology (fibromyalgia, gout, rheumatoid arthritis).
- BMI >30.
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- Having completed a strengthening exercise program in the last year.
- Visual disturbances that prevent being able to observe the cell phone screen correctly.
- Lack of digital skills in the use of the Internet with the cell phone.
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis is a very prevalent pathology after the fifth decade of life. It usually appears in the hip and hand, although its presence in the knee is even greater, with a prevalence in subjects over 45 years of age of 19% radiographically (radiographic findings without taking symptoms into account) and 7% in the symptomatic population, for those over 60 years of age, 37% radiographic and 12% symptomatic and finally, for those over 75 years of age there was 50% of osteoarthritis of the knee diagnosed by radiographs and 33% were symptomatic. There are gender differences: the lifetime risk of suffering knee osteoarthritis is estimated at 40% for men and 47% for women. Furthermore, the impact of this pathology is significant, being the most frequent cause of gait-related disability in adults in the United States.
Different approaches have been proposed for the treatment of knee osteoarthritis. Currently, clinical practice guidelines place therapeutic exercise and education as the first line of treatment, reserving joint replacement surgery in case of failure of conservative treatment and only if there is severe disability.
Read more
In recent years, due to the pandemic, there has been an accelerated development of telemedicine and telerehabilitation in all its aspects. Applications and websites have been developed for online rehabilitation. An example of this is TRAK, a telerehabilitation web tool that allows the creation of a profile for each patient and the design of personalized exercise programs and the periodization of the sessions to be carried out. During the execution of the exercises, the screen of the split phone will appear, displaying on one side the execution of the exercise by a model and on the other side, the patient sees himself performing the exercise. This tool allows the monitoring of the therapeutic exercise without the need to go to a consultation or to be in front of a physiotherapist, reducing the economic and time investment.
Thus, the present work tries to compare the treatment with exercises monitored by means of the TRAK application with the performance of the same exercises, without the help of this tool.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK, Standard home-based exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise supported by the digital physiotherapy and telerehabilitation software TRAKOther
8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software of digital physiotherapy and telerehabilitation TRAK. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows you to keep a record of the sessions. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
Standard home-based exerciseOther
8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted.. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
| Study group | Role | What they receive |
|---|---|---|
| Exercise supported by the digital physiotherapy and telerehabilitation software TRAK | Experimental | Home therapeutic exercise intervention scheduled through the software of digital physiotherapy and telerehabilitation TRAK Receives: Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK |
| Standard home-based exercise | Active comparator | Home therapeutic exercise program scheduled through a dossier and an exercise diary Receives: Other: Standard home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability measured using the scale Western Ontario and Mc Caster Universities Osteoarthritis (WOMAC) which consists in a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Pain
Numeric Rating Scale (NRS-11); the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Secondary outcomes (6)
40 metre fast-paced walk
Tests short distance walking ability with changing direction. A timed walk of 4 x 10 metres for a total of 40 metres.
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
30 seconds chair-stand test
The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand.
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Kinesiphobia
Kinesiofobia measured using the Tampa Scale of Kinesiofobia (range score from 17 [lower levels of kinesiophobia]-68 [higher levels of kinesiophobia])
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Medication intake
Medication intake registered using a diary
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Adherence measured using the TRAK application
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Adherence measured using an exercise diary
Measured: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 University of ValenciaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647446
- Sponsor's protocol ID
- 3407154
- Acronym
- KNEE_Telemon
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2024
- Last updated
- 4 May 2026
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Function and Pain in the Rehabilitation of Patients With Knee Osteoarthritis Using an Exercise Program Telemonitored Compared to Conventional Treatment
- ClinicalTrials.gov ID
- NCT06647446
- Acronym / sponsor ID
- KNEE_Telemon / 3407154
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Oct 2024 (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.
Osteoarthritis is a very prevalent pathology after the fifth decade of life. It usually appears in the hip and hand, although its presence in the knee is even greater, with a prevalence in subjects over 45 years of age of 19% radiographically (radiographic findings without taking symptoms into account) and 7% in the symptomatic population, for those over 60 years of age, 37% radiographic and 12% symptomatic and finally, for those over 75 years of age there was 50% of osteoarthritis of the knee diagnosed by radiographs and 33% were symptomatic. There are gender differences: the lifetime risk of suffering knee osteoarthritis is estimated at 40% for men and 47% for women. Furthermore, the impact of this pathology is significant, being the most frequent cause of gait-related disability in adults in the United States.
Different approaches have been proposed for the treatment of knee osteoarthritis. Currently, clinical practice guidelines place therapeutic exercise and education as the first line of treatment, reserving joint replacement surgery in case of failure of conservative treatment and only if there is severe disability.
In recent years, due to the pandemic, there has been an accelerated development of telemedicine and telerehabilitation in all its aspects. Applications and websites have been developed for online rehabilitation. An example of this is TRAK, a telerehabilitation web tool that allows the creation of a profile for each patient and the design of personalized exercise programs and the periodization of the sessions to be carried out. During the execution of the exercises, the screen of the split phone will appear, displaying on one side the execution of the exercise by a model and on the other side, the patient sees himself performing the exercise. This tool allows the monitoring of the therapeutic exercise without the need to go to a consultation or to be in front of a physiotherapist, reducing the economic and time investment.
Thus, the present work tries to compare the treatment with exercises monitored by means of the TRAK application with the performance of the same exercises, without the help of this tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise supported by the digital physiotherapy and telerehabilitation software TRAK | Experimental | Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAKHome therapeutic exercise intervention scheduled through the software of digital physiotherapy and telerehabilitation TRAK |
| Standard home-based exercise | Active comparator | Other: Standard home-based exerciseHome therapeutic exercise program scheduled through a dossier and an exercise diary |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient diagnosed with osteoarthritis of the knee.
- Age >45 years.
- The patient presents with knee pain during physical activity.
- The patient reports knee symptoms in the last month.
- The patient has a mobile phone with internet access.
Key exclusion criteria (9 listed)
- Previous knee surgeries.
- Planned surgeries during the duration of the trial.
- Patient is currently undergoing physical therapy.
- Patient currently has severe pathology that may compromise participation in the exercise program (advanced COPD, cardiac or arterial disease).
- Associated rheumatic pathology (fibromyalgia, gout, rheumatoid arthritis).
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 |
|---|---|---|
| Exercise supported by the digital physiotherapy and telerehabilitation software TRAK8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software of digital physiotherapy and telerehabilitation TRAK. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows you to keep a record of the sessions. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome. | Other | Exercise supported by the digital physiotherapy and telerehabilitation software TRAK |
| Standard home-based exercise8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted.. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome. | Other | Standard home-based exercise |
Primary outcome
Disability
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Disability measured using the scale Western Ontario and Mc Caster Universities Osteoarthritis (WOMAC) which consists in a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.
Pain
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Numeric Rating Scale (NRS-11); the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
6 secondary outcomes
40 metre fast-paced walk
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
30 seconds chair-stand test
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Kinesiphobia
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Medication intake
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Adherence
Time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
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 4 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise supported by the digital physiotherapy and telerehabilitation software TRAK and Standard home-based exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
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 5 inclusion and 9 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 4 May 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 Spain. 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?
Disability (time frame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)). The study lists 2 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 4 May 2026.