Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Glasgow Caledonian University | OTHER |
| Universität Münster | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to aging and increasing obesity, the prevalence of KOA is expected to increase in the developed country in the next 20 years. KOA decreases quality of life of patients through chronic pain, joint stiffness, and reduced social activity, which influence emotional wellness as well. KOA has also impact on the biomechanics of the lower limbs, leading or amplifying the tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the medial knee joint loading may lead patients into a vicious circle by increasing knee pain, decreasing activities, increasing weight and disease progression. Knee brace is a non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the limb. However, the main issue is the poor compliance because of lack of effectiveness, more drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness, aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in design, 3D printing may resolve most of these complaints.
This study aims to compare clinical and biomechanical effectiveness, comfort and patients complaints of a knee brace made by 3D printing to a conventional knee brace.
The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead the experimental trial. They will recruit men or women (40 to 70 years old) suffering from medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period, they will wear 2 different knee braces for two weeks each with a 1-week period without knee brace between. Participants will have five visits to GCU: once for leg measurement to make knee braces and four times to fill questionnaires and perform gait analysis. Besides, they will wear activity monitor for 3 non-consecutive weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KNEEMO knee brace & Popular knee brace | Experimental | Patients having medial knee osteoarthritis |
|
| Popular knee brace &KNEEMO knee brace | Experimental | Patients having medial knee osteoarthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KNEEMO knee brace | Device | Bespoke knee brace made by additive manufacturing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee pain during gait and stairs ambulation | Measured with 10-cm visual analog scale | Baseline and at 2 weeks |
| Change in knee adduction moment during gait and stairs ambulation | Knee adduction moment (KAM) will be calculated from motion capture and force plate data. KAM characterizes knee loading, especially peaks and angular impulse (area under the KAM curve) to have information about maximum and total knee loading, respectively. | Baseline and at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee brace comfort | Measured with 10-cm visual analog scale | Baseline and at 2 weeks |
| Change in stability feelings | Measured with 10-cm visual analog scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoann Dessery, PhD | Contact | yoann.dessery@peacocks.net | ||
| Jari Pallari, PhD | Contact | jari.pallari@peacocks.net |
| Name | Affiliation | Role |
|---|---|---|
| Yoann Dessery, PhD | Peacocks Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow Caledonian University | Recruiting | Glasgow | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Popular knee brace | Device | Customized knee brace used in the management of medial knee ostearthritis |
|
| Baseline and at 2 weeks |
| Change in Symptoms | KOOS questionnaires subscales | Baseline and at 2 weeks |
| Change in quality of life | MOS SF-36 questionnaires subscales | Baseline and at 2 weeks |
| Change in physical activities: Daily distance estimate | Measured (in km) during one week with an activity monitor. | Second week of intervention |
| Change in physical activities: Daily duration of sitting/standing/stair climbing | Measured in seconds during one week with an activity monitor. | Second week of intervention |
| Change in physical activities: Daily number of sitting/standing/stair climbing | Measured during one week with an activity monitor. | Second week of intervention |
| Change in physical activities: Weekly number of activities with moderate and high intensity | Measured during one week with an activity monitor. | Second week of intervention |
| Change in physical activities: Weekly duration of activities with moderate and high intensity | Measured in minutes during one week with an activity monitor. | Second week of intervention |
| Change in knee flexion moment during gait and stairs ambulation | Maximum knee flexion moment will be calculated from gait analysis data. | Baseline and at 2 weeks |
| Change in duration of phases of gait and stairs ambulation | Measured in percentage of gait cycle from gait analysis data. | Baseline and at 2 weeks |
| Change in step length of gait | Measured in meters from gait analysis data | Baseline and at 2 weeks |
| Change in knee flexion/extension range of motion during gait and stairs ambulation | Measured during the gait cycle based on gait analysis data | Baseline and at 2 weeks |
| Change in knee adduction/abduction range of motion during gait and stairs ambulation | Measured during the gait cycle based on gait analysis data | Baseline and at 2 weeks |
| D012216 |
| Rheumatic Diseases |