رادار التجارب AI | ||
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حالة التجربة السريرية NCT06251167 (MULTIWEDGE) لـ الفصال العظمي في الركبة هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة كولومبيا البريطانيةA Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis (MULTIWEDGE) ٣٦ عشوائية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06251167 (MULTIWEDGE) هي دراسة تدخُّلية لـالفصال العظمي في الركبة وهي يقبل مشاركين. بدأت في ٢٣ شعبان ١٤٤٥ هـ مع خطة لتجنيد ٣٦ مشاركًا. يقودها جامعة كولومبيا البريطانية، ومن المتوقع اكتمالها بحلول ١١ رجب ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٥ رمضان ١٤٤٦ هـ.
الملخص
Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.
العنوان الرسمي
A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
الحالات الطبية
الفصال العظمي في الركبةمعرّفات دراسة أخرى
- MULTIWEDGE
- H22-03584
NCT معرّف
تاريخ البدء (فعلي)
2024-03-04
آخر تحديث مُنشور
2025-03-25
تاريخ الاكتمال (المقدر)
2025-12-31
عدد المشاركين المخطط لهم
٣٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
Knee Osteoarthritis
Orthotics
Foot pain
Biomechanics
Orthotics
Foot pain
Biomechanics
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
مزدوج
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةLateral wedge insoles (LWIs) The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole. | Lateral wedge insoles (LWIs) Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge. |
تجريبيةLateral wedge plus custom arch support (LWAS) The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole. | Lateral wedge plus custom arch support (LWAS) Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens ...عرض المزيد |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Recruitment - number of screened patients who are eligible | The number of screened patients determined eligible to be enrolled in the study. | from onset of recruitment through study completion |
Retention - proportion of assessments with complete outcome measures data | Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol. | immediately after the intervention |
Insoles Delivery | Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study. | from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months |
Self-reported knee pain | Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%. | Baseline, 3 Months |
Self-reported foot pain | Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation. | Baseline, 3 Months |
External knee adduction moment impulse | The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach. | Baseline, 3 Months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Self-reported overall physical function | Physical function will be measured by the Function, Daily Living subscale (17 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%. | Baseline, 3 Months |
Self-reported foot function | Foot function will be measured at baseline and at 3-months by the Activity Limitations subscale (3 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation. | Baseline, 3 Months |
External knee flexion moment impulse | The external knee flexion moment impulse will be calculated using the same methods as described for the external knee adduction moment impulse. | Baseline, 3 Months |
Self-selected gait speed | Self-selected gait speed will be calculated during the biomechanical gait analyses. | Baseline, 3 Months |
Rearfoot eversion peak | Participants will walk on an instrumented walkway while high speed cameras track the trajectories of markers placed on bony landmarks. | Baseline, 3 Months |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
50 Years
الجنس المؤهل
الكل
- medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs
- history of knee pain longer than 6 months
- average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = "no pain" and 10 = "worst pain imaginable") over the 6 months prior to baseline testing
- pain in the same foot/feet as the painful knee(s)
- ability to communicate in English
- show an immediate biomechanical response to the insoles. This final eligibility criterion will be determined from an in-person biomechanical assessment after participants have passed all previous eligibility screening.
- radiographic evidence of more lateral tibiofemoral OA than medial
- knee surgery or intra-articular injection within the previous 6 months
- current or recent (within 6 months) corticosteroid use for any reason
- presence of a systemic arthritic condition
- history of knee joint replacement or tibial osteotomy
- any other condition affecting lower limb function
- current usage of shoe-worn insoles, or planning to acquire footwear modifications in the next 6 months
- any previous experience with insoles that resulted in increased lower limb pain or a self- or clinician-initiated termination of use.
جامعة كولومبيا البريطانية318 تجارب سريرية نشطة للاستكشاف- Western University
- Dalhousie University
الجهة المسؤولة عن الدراسة
Michael Hunt, المحقق الرئيسي, Professor, University of British Columbia
جهة اتصال مركزية للدراسة
جهة اتصال: Natasha Krowchuk, 604-822-7948, [email protected]
1 مواقع الدراسة في 1 بلدان
British Columbia
Motion Analysis and Biofeedback Laboratory, Vancouver, British Columbia, V5R 3N9, Canada
Natasha Krowchuk, جهة اتصال, 6048227948
يقبل مشاركين