Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease (JC3D)

MDH sp. z o.o.

Status: Active, not recruiting

Conditions: Knee Brace; Joint Diseases; Knee Osteoarthritis (OA)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07188493

JC3D/2024

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 3 patient groups

Group A

Description:

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

Description:

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

Description:

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)