Knee Osteoarthritis (OA)JC3DNCT07188493
Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease
An observational study of Knee Osteoarthritis (OA) and Joint Diseases, run by MDH sp. z o.o. at 1 site in Poland.
Trial summary
The goal of this observational study is to learn how well remote rehabilitation and offloading the inner part of the knee joint using a custom-made knee brace work as non-surgical treatments for people with unicompartmental knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (OA), Joint Diseases, Knee Brace
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 31 May 2024to 30 Sep 2025
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be observed from patients receiving conservative treatment for medial compartment knee osteoarthritis at the Sporto Clinic. The study population includes adults aged 45 to 75 years diagnosed with unicompartmental knee osteoarthritis (Kellgren-Lawrence grade I-III) in one lower limb, confirmed by imaging. Participants are community-dwelling individuals able to follow a home-based exercise program and use a functional knee brace.
Who may be able to join
- Unicompartmental knee osteoarthritis (medial compartment), Kellgren-Lawrence grade I-III, confirmed by imaging; affecting one lower limb (with predominant symptoms in either the right or left leg)
- Age between 45 and 75 years
- Preserved passive knee extension; flexion contracture of up to 20 degrees of extension deficit is acceptable
- Signed informed consent for participation in the clinical investigation
Who cannot join
- Bicompartmental knee osteoarthritis with similar symptom severity in both compartments
- Neurological disorders
- Rheumatoid arthritis
- Coexisting dysfunctions of the hip and/or ankle joint of the affected limb
- Ligament injuries (ACL, PCL, MCL, LCL) and/or meniscus injuries (medial or lateral) causing significant joint instability (moderate instability due to ligament insufficiency, common in osteoarthritis, is not excluded)
- Bone fractures
Show all 11Show fewer
- Sensory disturbances in the lower limbs
- Passive knee extension deficit greater than 20 degrees
- Major surgical procedures involving the knee joint within the last 6 months
- Lack of informed consent and/or inability to establish reliable verbal-logical communication with the participant
- Other medical conditions preventing independent application of the brace and/or use of the mobile application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis and Evaluation of the Effectiveness of Remote Rehabilitation Using a Knee Brace in People With Degenerative Disease
The goal of this observational study is to learn how well remote rehabilitation and offloading the inner part of the knee joint using a custom-made knee brace work as non-surgical treatments for people with unicompartmental knee osteoarthritis.
The main question it aims to answer is:
Read more
Does the remote rehabilitation system improve symptoms and function in people with knee osteoarthritis?
Researchers will compare three groups of participants to see how different types of knee braces and rehabilitation methods affect outcomes:
Group A will use a custom-made knee brace connected to a mobile app and motion sensors.
Group B will use a custom-made knee brace daily and perform prescribed exercises.
Group C will use a standard off-the-shelf functional knee brace daily and perform the same prescribed exercises.
Participants will:
Wear their assigned brace for 6 months
Complete surveys (VAS, KOOS, and Laitinen)
Have their knee range of motion and body weight measured
- Conditions
- Knee Osteoarthritis (OA), Joint Diseases, Knee Brace
- Keywords
- OA, orthosis, telerehabilitation, knee brace, knee, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Participants in this group follow a complete telerehabilitation protocol, including: * An individually tailored home-based kinesitherapy program delivered through the Qmed Play mobile application * A custom-made rehabilitation knee brace (Jointcraft 3D Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) integrated with motion sensors (Qmed Sensors, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) and the Qmed Play mobile application | |
| Group B | Participants in this group receive: * An individually tailored home-based kinesitherapy program * A custom-made rehabilitation knee brace (Jointcraft 3D Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) | |
| Group C | Participants in this group receive: * An individually tailored home-based kinesitherapy program * A standard functional knee brace (Follow Force Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)
The KOOS questionnaire is a validated and internationally recognized self-reported tool, officially translated into Polish, used to assess knee-related symptoms. It consists of five subscales: pain, knee stiffness, daily living function, sports and recreational activity, and knee-related quality of life.
The maximum score of 100 indicates no symptoms or limitations, while a score of 0 indicates extreme symptom severity.
Measured: At first and final visit (6 months)
VAS Scale (Visual Analog Scale)
A subjective scale for evaluating pain intensity. This 10-point scale measures how strong the participant's pain is, where 1 means no pain and 10 means unbearable pain.
Measured: At first and final visit (6 months)
Laitinen Scale
A subjective, point-based tool assessing pain based on four features: intensity, frequency, use of pain medication, and physical activity limitation.
Each category is scored from 0 to 4, where 0 means no issue, and 4 indicates the most severe problem.
Measured: At first and final visit (6 months)
Lower Limb Ortogram
Anteroposterior (AP) radiograph of both lower limbs taken in a standing position, with feet hip-width apart and in a neutral position.
Measurements include the angle between the mechanical axis of the femur and tibia, and the medial joint space width (JSW) of the knee [mm].
Measured: At first and final visit (6 months)
Range of Motion (ROM) of the Knee Joint
Angular measurement of the knee's flexion and extension using an electronic goniometer.
For flexion: the patient lies on their back with legs extended; the goniometer axis is placed at the lateral femoral epicondyle, with the fixed arm aligned with the greater trochanter and the movable arm following the lateral malleolus as the patient actively bends the knee.
For extension: the patient lies face down with legs bent at the knees, positioned so that the knees extend beyond the edge of the examination table to allow full extension or hyperextension. Goniometer placement follows the same protocol.
Measurements are taken for both limbs.
Measured: At first and final visit (6 months)
Custom Satisfaction Questionnaire
A proprietary survey assessing patient satisfaction with the telerehabilitation program, as well as comfort and perceived effectiveness of the cage-type knee brace used in the conservative treatment of knee osteoarthritis. The survey is based on a 5-point scale, where 1 represents a poor outcome, 5 indicates an excellent result, and 3 denotes no change.
Measured: At the final visit (6 months)
Secondary outcomes (2)
BMI (Body Mass Index)
BMI is calculated as weight [kg] divided by height squared [m²]. It is considered a significant risk factor in the severity and progression of knee osteoarthritis.
A simplified BMI classification is used in this study:
<18.5 - underweight; 18.5-24.99 - normal; >24.99 - overweight
Measured: At first and final visit (6 months)
Lower Limb Circumference Measurements
Circumference measurements (in cm) of the thigh (10 cm above mid-patella), knee (at mid-patella), and calf (15 cm below mid-patella) on both braced and non-braced limb; used for asymmetry assessment, monitoring changes over time, and brace sizing.
Measured: At first and final visit (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start31 May 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDH sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sporto Clinic
- Responsible party
- Sponsor
- Investigators
- Marcin Domżalski, M.D., Principal investigator, Sporto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188493
- Sponsor's protocol ID
- JC3D/2024
- Acronym
- JC3D
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small, single-center population, and the data include potentially identifiable medical and imaging information. The data are intended for internal analysis and publication in aggregate form only.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis and Evaluation of the Effectiveness of Remote Rehabilitation Using a Knee Brace in People With Degenerative Disease
- ClinicalTrials.gov ID
- NCT07188493
- Acronym / sponsor ID
- JC3D / JC3D/2024
- Conditions
- Knee Osteoarthritis (OA), Joint Diseases, Knee Brace
- Keywords
- OA, orthosis, telerehabilitation, knee brace, knee, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- MDH sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Sporto Clinic
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Sep 2025 (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.
The goal of this observational study is to learn how well remote rehabilitation and offloading the inner part of the knee joint using a custom-made knee brace work as non-surgical treatments for people with unicompartmental knee osteoarthritis.
The main question it aims to answer is:
Does the remote rehabilitation system improve symptoms and function in people with knee osteoarthritis?
Researchers will compare three groups of participants to see how different types of knee braces and rehabilitation methods affect outcomes:
Group A will use a custom-made knee brace connected to a mobile app and motion sensors.
Group B will use a custom-made knee brace daily and perform prescribed exercises.
Group C will use a standard off-the-shelf functional knee brace daily and perform the same prescribed exercises.
Participants will:
Wear their assigned brace for 6 months
Complete surveys (VAS, KOOS, and Laitinen)
Have their knee range of motion and body weight measured
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Participants in this group follow a complete telerehabilitation protocol, including: * An individually tailored home-based kinesitherapy program delivered through the Qmed Play mobile application * A custom-made rehabilitation knee brace (Jointcraft 3D Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) integrated with motion sensors (Qmed Sensors, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) and the Qmed Play mobile application |
| Group B | – | –Participants in this group receive: * An individually tailored home-based kinesitherapy program * A custom-made rehabilitation knee brace (Jointcraft 3D Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) |
| Group C | – | –Participants in this group receive: * An individually tailored home-based kinesitherapy program * A standard functional knee brace (Follow Force Knee Brace with range-of-motion adjustment, MDH sp. z o.o., Maratońska 104, 94-007 Łódź, Poland) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be observed from patients receiving conservative treatment for medial compartment knee osteoarthritis at the Sporto Clinic. The study population includes adults aged 45 to 75 years diagnosed with unicompartmental knee osteoarthritis (Kellgren-Lawrence grade I-III) in one lower limb, confirmed by imaging. Participants are community-dwelling individuals able to follow a home-based exercise program and use a functional knee brace.
Key inclusion criteria (4 listed)
- Unicompartmental knee osteoarthritis (medial compartment), Kellgren-Lawrence grade I-III, confirmed by imaging; affecting one lower limb (with predominant symptoms in either the right or left leg)
- Age between 45 and 75 years
- Preserved passive knee extension; flexion contracture of up to 20 degrees of extension deficit is acceptable
- Signed informed consent for participation in the clinical investigation
Key exclusion criteria (11 listed)
- Bicompartmental knee osteoarthritis with similar symptom severity in both compartments
- Neurological disorders
- Rheumatoid arthritis
- Coexisting dysfunctions of the hip and/or ankle joint of the affected limb
- Ligament injuries (ACL, PCL, MCL, LCL) and/or meniscus injuries (medial or lateral) causing significant joint instability (moderate instability due to ligament insufficiency, common in osteoarthritis, is not excluded)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)
Time frame: At first and final visit (6 months)
The KOOS questionnaire is a validated and internationally recognized self-reported tool, officially translated into Polish, used to assess knee-related symptoms. It consists of five subscales: pain, knee stiffness, daily living function, sports and recreational activity, and knee-related quality of life. The maximum score of 100 indicates no symptoms or limitations, while a score of 0 indicates extreme symptom severity.
VAS Scale (Visual Analog Scale)
Time frame: At first and final visit (6 months)
A subjective scale for evaluating pain intensity. This 10-point scale measures how strong the participant's pain is, where 1 means no pain and 10 means unbearable pain.
Laitinen Scale
Time frame: At first and final visit (6 months)
A subjective, point-based tool assessing pain based on four features: intensity, frequency, use of pain medication, and physical activity limitation. Each category is scored from 0 to 4, where 0 means no issue, and 4 indicates the most severe problem.
Lower Limb Ortogram
Time frame: At first and final visit (6 months)
Anteroposterior (AP) radiograph of both lower limbs taken in a standing position, with feet hip-width apart and in a neutral position. Measurements include the angle between the mechanical axis of the femur and tibia, and the medial joint space width (JSW) of the knee [mm].
Range of Motion (ROM) of the Knee Joint
Time frame: At first and final visit (6 months)
Angular measurement of the knee's flexion and extension using an electronic goniometer. For flexion: the patient lies on their back with legs extended; the goniometer axis is placed at the lateral femoral epicondyle, with the fixed arm aligned with the greater trochanter and the movable arm following the lateral malleolus as the patient actively bends the knee. For extension: the patient lies face down with legs bent at the knees, positioned so that the knees extend beyond the edge of the examination table to allow full extension or hyperextension. Goniometer placement follows the same protocol. Measurements are taken for both limbs.
Custom Satisfaction Questionnaire
Time frame: At the final visit (6 months)
A proprietary survey assessing patient satisfaction with the telerehabilitation program, as well as comfort and perceived effectiveness of the cage-type knee brace used in the conservative treatment of knee osteoarthritis. The survey is based on a 5-point scale, where 1 represents a poor outcome, 5 indicates an excellent result, and 3 denotes no change.
2 secondary outcomes
BMI (Body Mass Index)
Time frame: At first and final visit (6 months)
Lower Limb Circumference Measurements
Time frame: At first and final visit (6 months)
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 24 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small, single-center population, and the data include potentially identifiable medical and imaging information. The data are intended for internal analysis and publication in aggregate form only.
Related trials for Knee Osteoarthritis (OA)
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
RecruitingPhase 3
A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
Obesity, Overweight and/or Obesity
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
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.
Marcin Domżalski, M.D. principal investigator
Sporto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis (OA) and Joint Diseases, run by MDH sp. z o.o. at 1 site in Poland.
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 4 inclusion and 11 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 24 Feb 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 Poland. 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?
KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score) (time frame: At first and final visit (6 months)). The study lists 6 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 24 Feb 2026.