Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease
NCT ID: NCT07188493
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2024-05-31
2025-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
45 Years
75 Years
ALL
No
Sponsors
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Sporto Clinic
OTHER
MDH sp. z o.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Marcin Domżalski, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sporto
Locations
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Sporto
Lodz, , Poland
Countries
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Other Identifiers
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JC3D/2024
Identifier Type: -
Identifier Source: org_study_id
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