Clinical trial NCT05435040: Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
Official title: Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proprioceptive Disorders
Keywords: anterior cruciate ligaments rupture
proprioceptive knee brace
rehabilitation
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient with a proprioception deficit of the knee: detection threshold higher than 2.5° on the TTDPM (Threshold to detect passive motion) test
* Patient whose knee measurements are compatible with the sizes of the proprioceptive knee brace
* Patient having signed a free and informed consent form
* Patient affiliated or entitled to a social security plan

Exclusion Criteria:

* Patient with knee pain on walking greater than or equal to 4 out of 10 on a VAS scale.
* Patient in the early phase of acute trauma to the lower limb
* Patient having worn a knee brace in the 48 hours prior to inclusion
* Pregnant women
* Patient presenting one of the contraindications to the use of the knee brace, indicated in the instructions for use
* Patient with a major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the conformity of a DM (Medical Device) impacting the judgment criteria
* Vulnerable patient according to article L1121-6 of the public health code, person subject to a judicial protection measure or unable to consent freely

Primary outcomes:
measure: Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
Secondary outcomes:
measure: Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the sensitivity to the position of a joint with or without wearing the knee brace
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the static stability when using or not the knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the stability when walking when using or not the knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the discomfort level when using or not the knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the fluidity level when using or not the knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of the range of motion ok the knee level when using or not the knee brace.
timeFrame: Day 1 (2 times, after condition 1 and after condition 2)
measure: Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire
timeFrame: Day 1
measure: Evaluation of the patient's tolerance to the use of the knee brace.
timeFrame: Day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la sauvegarde
Study officials:
affiliation: Clinique de la Sauvegarde
name: Roger OULLION, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.