Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease

NCT ID: NCT07188493

Last Updated: 2025-09-29

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Knee Osteoarthritis (OA) Joint Diseases Knee Brace

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sporto Clinic

OTHER

Sponsor Role collaborator

MDH sp. z o.o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcin Domżalski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sporto

Locations

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Sporto

Lodz, , Poland

Site Status

Countries

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Poland

Other Identifiers

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JC3D/2024

Identifier Type: -

Identifier Source: org_study_id

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