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

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.

Study Overview

• Status: Completed
• Conditions: Proprioceptive Disorders
• Intervention / Treatment: Device: proprioceptive knee brace; Device: No knee brace

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucile BARBIN, CRA; Email: lucile.barbin@thuanse.fr

Study Locations

• France
  • Lyon, France
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: self-comparison; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Thuasne
• Investigators: Principal Investigator: Roger OULLION, MD, Clinique de la Sauvegarde

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): November 24, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; anterior cruciate ligaments rupture; proprioceptive knee brace
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders
• Other Study ID Numbers: 2022-A00676-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No