Status:
ACTIVE_NOT_RECRUITING
Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease
Lead Sponsor:
MDH sp. z o.o.
Collaborating Sponsors:
Sporto Clinic
Conditions:
Knee Osteoarthritis (OA)
Joint Diseases
Eligibility:
All Genders
45-75 years
Brief 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 peopl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07188493
Start Date
May 31 2024
End Date
September 30 2025
Last Update
September 29 2025
Active Locations (1)
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1
Sporto
Lodz, Poland, 90-038