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Completed

NCT Number: NCT05435040

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la sauvegarde

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proprioceptive knee brace

Device

the patient will perform the tests with the knee brace

No knee brace

Device

the patient will perform the tests without the knee brace

Primary outcomes

  1. Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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.

Secondary outcomes

  1. Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    Tactile sensitivity (Baresthesia) via the use of Weinstein monofilaments.

  2. Evaluation of the sensitivity to the position of a joint with or without wearing the knee brace

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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.

  3. Evaluation of the static stability when using or not the knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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).

  4. Evaluation of the stability when walking when using or not the knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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).

  5. Evaluation of the discomfort level when using or not the knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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).

  6. Evaluation of the fluidity level when using or not the knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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).

  7. Evaluation of the range of motion ok the knee level when using or not the knee brace.

    Time frame: Day 1 (2 times, after condition 1 and after condition 2)

    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).

  8. Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire

    Time frame: Day 1

    Patient satisfaction with the use of the knee brace via a specific questionnaire composed of 15 questions.

  9. Evaluation of the patient's tolerance to the use of the knee brace.

    Time frame: Day 1

    Evaluation of the patient's tolerance to the use of the knee brace through the collection of adverse events.

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Acronym: CAPROG

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2022
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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