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

NCT ID: NCT05435040

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2022-11-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Proprioceptive Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

the clinical trial is carried out in open label

Study Groups

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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.

Group Type EXPERIMENTAL

proprioceptive knee brace

Intervention Type DEVICE

the patient will perform the tests with the knee brace

No knee brace

Intervention Type DEVICE

the patient will perform the tests without the knee brace

Interventions

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proprioceptive knee brace

the patient will perform the tests with the knee brace

Intervention Type DEVICE

No knee brace

the patient will perform the tests without the knee brace

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thuasne

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger OULLION, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique de la Sauvegarde

Locations

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Clinique de la sauvegarde

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16558671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2036801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16646628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10990300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30356896 (View on PubMed)

Other Identifiers

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2022-A00676-37

Identifier Type: -

Identifier Source: org_study_id

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