Analysis and Evaluation of the Effectiveness of Remote Rehabilitation Using a Knee Brace in People With Degenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
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
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)
结局指标
主要结局
KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)
时间窗: At first and final visit (6 months)
The KOOS questionnaire is a validated and internationally recognized self-reported tool, officially translated into Polish, used to assess knee-related symptoms. It consists of five subscales: pain, knee stiffness, daily living function, sports and recreational activity, and knee-related quality of life. The maximum score of 100 indicates no symptoms or limitations, while a score of 0 indicates extreme symptom severity.
Lower Limb Ortogram
时间窗: At first and final visit (6 months)
Anteroposterior (AP) radiograph of both lower limbs taken in a standing position, with feet hip-width apart and in a neutral position. Measurements include the angle between the mechanical axis of the femur and tibia, and the medial joint space width (JSW) of the knee \[mm\].
VAS Scale (Visual Analog Scale)
时间窗: At first and final visit (6 months)
A subjective scale for evaluating pain intensity. This 10-point scale measures how strong the participant's pain is, where 1 means no pain and 10 means unbearable pain.
Laitinen Scale
时间窗: At first and final visit (6 months)
A subjective, point-based tool assessing pain based on four features: intensity, frequency, use of pain medication, and physical activity limitation. Each category is scored from 0 to 4, where 0 means no issue, and 4 indicates the most severe problem.
Custom Satisfaction Questionnaire
时间窗: At the final visit (6 months)
A proprietary survey assessing patient satisfaction with the telerehabilitation program, as well as comfort and perceived effectiveness of the cage-type knee brace used in the conservative treatment of knee osteoarthritis. The survey is based on a 5-point scale, where 1 represents a poor outcome, 5 indicates an excellent result, and 3 denotes no change.
Range of Motion (ROM) of the Knee Joint
时间窗: At first and final visit (6 months)
Angular measurement of the knee's flexion and extension using an electronic goniometer. For flexion: the patient lies on their back with legs extended; the goniometer axis is placed at the lateral femoral epicondyle, with the fixed arm aligned with the greater trochanter and the movable arm following the lateral malleolus as the patient actively bends the knee. For extension: the patient lies face down with legs bent at the knees, positioned so that the knees extend beyond the edge of the examination table to allow full extension or hyperextension. Goniometer placement follows the same protocol. Measurements are taken for both limbs.
次要结局
- BMI (Body Mass Index)(At first and final visit (6 months))
- Lower Limb Circumference Measurements(At first and final visit (6 months))