Back to resultsEvaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits (CAPROG)
Primary Purpose
Proprioceptive Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
proprioceptive knee brace
No knee brace
Sponsored by
About this trial
This is an interventional treatment trial for Proprioceptive Disorders focused on measuring anterior cruciate ligaments rupture, proprioceptive knee brace, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Clinique de la sauvegarde
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
self-comparison
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace
Tactile sensitivity (Baresthesia) via the use of Weinstein monofilaments.
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.
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).
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).
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).
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).
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05435040
Brief Title
Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
Acronym
CAPROG
Official Title
Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
November 24, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thuasne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proprioceptive Disorders
Keywords
anterior cruciate ligaments rupture, proprioceptive knee brace, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
the clinical trial is carried out in open label
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-comparison
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
proprioceptive knee brace
Intervention Description
the patient will perform the tests with the knee brace
Intervention Type
Device
Intervention Name(s)
No knee brace
Intervention Description
the patient will perform the tests without the knee brace
Primary Outcome Measure Information:
Title
Comparison of the functional proprioceptive capacity of the knee in patients with proprioceptive deficit with or without wearing an elastic proprioceptive knee brace.
Description
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.
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Secondary Outcome Measure Information:
Title
Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace
Description
Tactile sensitivity (Baresthesia) via the use of Weinstein monofilaments.
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the sensitivity to the position of a joint with or without wearing the knee brace
Description
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.
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the static stability when using or not the knee brace.
Description
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).
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the stability when walking when using or not the knee brace.
Description
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).
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the discomfort level when using or not the knee brace.
Description
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).
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the fluidity level when using or not the knee brace.
Description
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).
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of the range of motion ok the knee level when using or not the knee brace.
Description
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).
Time Frame
Day 1 (2 times, after condition 1 and after condition 2)
Title
Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire
Description
Patient satisfaction with the use of the knee brace via a specific questionnaire composed of 15 questions.
Time Frame
Day 1
Title
Evaluation of the patient's tolerance to the use of the knee brace.
Description
Evaluation of the patient's tolerance to the use of the knee brace through the collection of adverse events.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger OULLION, MD
Organizational Affiliation
Clinique de la Sauvegarde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de la sauvegarde
City
Lyon
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16558671
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.
Results Reference
background
PubMed Identifier
2036801
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.
Results Reference
background
PubMed Identifier
16646628
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.
Results Reference
background
PubMed Identifier
10990300
Citation
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.
Results Reference
background
PubMed Identifier
30356896
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.
Results Reference
background
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Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
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