CompletedNot Applicable

Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease

Poland36 participantsStarted 2024-05-31

Plain-language 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. 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

Who can participate

Age range45 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)

Timeframe: At first and final visit (6 months)

VAS Scale (Visual Analog Scale)

Timeframe: At first and final visit (6 months)

Laitinen Scale

Timeframe: At first and final visit (6 months)

Lower Limb Ortogram

Timeframe: At first and final visit (6 months)

Range of Motion (ROM) of the Knee Joint

Timeframe: At first and final visit (6 months)

Custom Satisfaction Questionnaire

Timeframe: At the final visit (6 months)

Trial details

NCT IDNCT07188493

SponsorMDH sp. z o.o.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Knee Osteoarthritis (OA) trials

Plain-language summary

Who can participate

Age range45 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)

Timeframe: At first and final visit (6 months)

VAS Scale (Visual Analog Scale)

Timeframe: At first and final visit (6 months)

Laitinen Scale

Timeframe: At first and final visit (6 months)

Lower Limb Ortogram

Timeframe: At first and final visit (6 months)

Range of Motion (ROM) of the Knee Joint

Timeframe: At first and final visit (6 months)

Custom Satisfaction Questionnaire

Timeframe: At the final visit (6 months)