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

T

THUASNE

Status

Completed

Conditions

Proprioceptive Disorders

Treatments

Device: proprioceptive knee brace
Device: No knee brace

Study type

Interventional

Funder types

Industry

Identifiers

NCT05435040
2022-A00676-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

self-comparison
Experimental group
Description:
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.
Treatment:
Device: No knee brace
Device: proprioceptive knee brace

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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