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The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.
This proprioceptive deficit is found following various traumas or injuries such as Anterior Cruciate Ligament (ACL) rupture, for example.
The use of joint stabilizers (such as knee braces) will allow an increase in sensory input (particularly at the level of cutaneous mechanoreceptors), and improve the biomechanics of the injured joint.
The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-comparison | Experimental | The patient will be fitted with proprioceptive knee brace and with no knee brace. the patient will perform tests (Y Balance Test, test with Weinstein monofilaments, and Joint Position Sense test) and complete visual analog scales with and without the proprioceptive knee brace in a randomized order. There is also a satisfaction questionnaire regarding the proprioceptive knee brace to be completed at the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proprioceptive knee brace | Device | the patient will perform the tests with the knee brace |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace. | The functional proprioceptive capacity of the knee is measured via the 3-axis composite score of the Y Balance Test (YBT). This score corresponds to the average of the 3 maximum distances obtained during the YBT test, normalized by leg length. | Day 1 (2 times, after condition 1 and after condition 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace | Tactile sensitivity (Baresthesia) via the use of Weinstein monofilaments. | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the sensitivity to the position of a joint with or without wearing the knee brace |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger OULLION, MD | Clinique de la Sauvegarde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la sauvegarde | Lyon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16558671 | Background | Riemann BL, Lephart SM. The Sensorimotor System, Part II: The Role of Proprioception in Motor Control and Functional Joint Stability. J Athl Train. 2002 Jan;37(1):80-4. | |
| 2036801 | Background | Johansson H, Sjolander P, Sojka P. Receptors in the knee joint ligaments and their role in the biomechanics of the joint. Crit Rev Biomed Eng. 1991;18(5):341-68. |
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| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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This is a prospective, single-center, interventional, open-label, 1-day clinical investigation in a population of patients with proprioceptive knee deficiency. A randomization will be performed in order to know the order of passage of the 2 conditions: with and without wearing a knee brace.
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the clinical trial is carried out in open label
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| No knee brace | Device | the patient will perform the tests without the knee brace |
|
Sensitivity to the position of a joint by determining the perception of the position of the leg in space via the JPS (Joint Position Sense) test. |
| Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the static stability when using or not the knee brace. | Static stability level is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no stability (worst outcome) and 10 to maximum stability (better outcome). | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the stability when walking when using or not the knee brace. | Stability level when walking is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no stability (worst outcome) and 10 to maximum stability (better outcome). | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the discomfort level when using or not the knee brace. | Discomfort level when walking is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no discomfort (better outcome) and 10 to maximum discomfort (worst outcome). | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the fluidity level when using or not the knee brace. | Fluidity level is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no fluidity (worst outcome) and 10 to maximum fluidity (better outcome). | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of the range of motion ok the knee level when using or not the knee brace. | Range of motion of the knee level is measured by Visual Analogic Scale (VAS) completed by the patient : 0 corresponds to no range of motion (worst outcome) and 10 to maximum range of motion (better outcome). | Day 1 (2 times, after condition 1 and after condition 2) |
| Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire | Patient satisfaction with the use of the knee brace via a specific questionnaire composed of 15 questions. | Day 1 |
| Evaluation of the patient's tolerance to the use of the knee brace. | Evaluation of the patient's tolerance to the use of the knee brace through the collection of adverse events. | Day 1 |
| 16646628 | Background | Wikstrom EA, Tillman MD, Chmielewski TL, Borsa PA. Measurement and evaluation of dynamic joint stability of the knee and ankle after injury. Sports Med. 2006;36(5):393-410. doi: 10.2165/00007256-200636050-00003. |
| 10990300 | Background | Fremerey RW, Lobenhoffer P, Zeichen J, Skutek M, Bosch U, Tscherne H. Proprioception after rehabilitation and reconstruction in knees with deficiency of the anterior cruciate ligament: a prospective, longitudinal study. J Bone Joint Surg Br. 2000 Aug;82(6):801-6. doi: 10.1302/0301-620x.82b6.10306. |
| 30356896 | Background | Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3. |
| D013568 | Pathological Conditions, Signs and Symptoms |