Proprioceptive DisordersCAPROGNCT05435040
Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
A study testing proprioceptive knee brace and No knee brace in people with Proprioceptive Disorders, run by Thuasne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- proprioceptive knee brace and No knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 24 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Proprioceptive Disorders
- Being tested
- proprioceptive knee brace, No knee brace
- Keywords
- anterior cruciate ligaments rupture, proprioceptive knee brace, rehabilitation
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive knee braceDevice
the patient will perform the tests with the knee brace
No knee braceDevice
the patient will perform the tests without the knee brace
| Study group | Role | What they receive |
|---|---|---|
| self-comparison | Experimental | 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. Receives: Device: proprioceptive knee brace; Device: No knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (2 times, after condition 1 and after condition 2)
Secondary outcomes (9)
Evaluation of tactile sensitivity (baresthesia) with or without wearing the knee brace
Tactile sensitivity (Baresthesia) via the use of Weinstein monofilaments.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start19 Oct 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Proprioceptive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger OULLION, MD, Principal investigator, Clinique de la Sauvegarde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435040
- Sponsor's protocol ID
- 2022-A00676-37
- Acronym
- CAPROG
- Status last verified
- Apr 2023
- First submitted
- 14 Jun 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16558671Johansson 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.
PubMed 2036801Wikstrom 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.
PubMed 16646628Fremerey 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.
PubMed 10990300Han 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.
PubMed 30356896
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits
- ClinicalTrials.gov ID
- NCT05435040
- Acronym / sponsor ID
- CAPROG / 2022-A00676-37
- Conditions
- Proprioceptive Disorders
- Keywords
- anterior cruciate ligaments rupture, proprioceptive knee brace, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| self-comparison | Experimental | Device: proprioceptive knee brace, Device: No knee braceThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioceptive knee bracethe patient will perform the tests with the knee brace | Device | self-comparison |
| No knee bracethe patient will perform the tests without the knee brace | Device | self-comparison |
Primary outcome
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.
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Evaluation of patient satisfaction with the use of the knee brace with a specific questionnaire
Time frame: Day 1
Evaluation of the patient's tolerance to the use of the knee brace.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 16558671Riemann 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.
- Background: PubMed 2036801Johansson 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.
- Background: PubMed 16646628Wikstrom 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.
- Background: PubMed 10990300Fremerey 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.
- Background: PubMed 30356896Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger OULLION, MD principal investigator
Clinique de la Sauvegarde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive knee brace and No knee brace in people with Proprioceptive Disorders, run by Thuasne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435040, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.