Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

Proprioceptive Disorders Clinical Trial

— CAPROG  

Official title:

Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435040
• Other study ID #: 2022-A00676-37
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: November 24, 2022

Study information

• Verified date: April 2023
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Proprioceptive Disorders
• Somatosensory Disorders

Intervention

Device:
• proprioceptive knee brace
the patient will perform the tests with the knee brace
• No knee brace
the patient will perform the tests without the knee brace

Locations

Country	Name	City	State
France	Clinique de la sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Evaluation of the sensitivity to the position of a joint with or without wearing 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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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