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

NCT05435040 | Completed

• 1 other identifier: 2022-A00676-37
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Proprioceptive Disorders

Keywords

anterior cruciate ligaments rupture; proprioceptive knee brace; rehabilitation

Outcome Measures

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.

  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.

  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

  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

  Day 1 (2 times, after condition 1 and after condition 2)

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

  Day 1 (2 times, after condition 1 and after condition 2)

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

  Day 1 (2 times, after condition 1 and after condition 2)

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

  Day 1 (2 times, after condition 1 and after condition 2)

Study Arms (1)

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.

Device: proprioceptive knee brace; Device: No knee brace

Interventions

proprioceptive knee brace DEVICE

the patient will perform the tests with the knee brace

self-comparison

No knee brace DEVICE

the patient will perform the tests without the knee brace

self-comparison

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

Clinique de la sauvegarde

Lyon, France

Location

Related Publications (5)

• 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.

  PMID: 16558671 BACKGROUND

• 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.

  PMID: 2036801 BACKGROUND

• 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.

  PMID: 16646628 BACKGROUND

• 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.

  PMID: 10990300 BACKGROUND

• 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.

  PMID: 30356896 BACKGROUND

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger OULLION, MD

  Clinique de la Sauvegarde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the clinical trial is carried out in open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 28, 2022
• Study Start: October 19, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)