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临床试验/CTRI/2024/09/074052
CTRI/2024/09/074052尚未招募不适用

Comparison of proprioception in the unaffected knee of patient with unilateral knee osteoarthritis with healthy age and gender matched individual - An Observational Study.

未提供1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Proprioception (joint position sense error)

研究概览

简要总结

NEED OF STUDY

The Physiotherapy OPD receives many patients with knee osteoarthritis, it is most common condition that diminishes mobility and induces pain. Despite the prevalence of knee OA, there is a noticeable gap in our understanding of how it specifically influences proprioception – the body’s ability to sense and control movement. This study aims to explore the proprioceptive aspects of the unaffected knee in patient with unilateral knee OA compared to those without knee pain. Knee OA is known to alter joint mechanics and impact daily activities, but its precise effect on proprioception, especially in the unaffected leg, remain unclear. Proprioception is vital for coordinating movements and maintaining balance, making it crucial to investigate whether knee OA extends its influence beyond the directly affected joint. Existing research primarily focuses on proprioception in the affected leg or general functional limitations in knee OA. However, studies specifically exploring proprioceptive changes in the unaffected leg are limited. This study will contribute by building upon the existing literature and providing a more comprehensive understanding of proprioceptive alterations in knee OA. Understanding proprioception in the unaffected leg is essential for several reasons. First, it can shed light on whether knee OA has a systemic impact on proprioceptive abilities. Second, identifying specific proprioceptive changes may offer insights into how the body compensates for the affected knee. Lastly, this knowledge could have direct implications for designing targeted rehabilitation programs that not only address the affected joint but also consider the overall proprioceptive function.

AIM

To Compare the Proprioception in Unaffected Knee of Patient with Unilateral Knee Osteoarthritis with healthy age and gender matched individual.

OBJECTIVES

  1. To assess proprioception in affected knee of patient with unilateral knee OA.

  2. To assess proprioception in unaffected knee of patient with unilateral knee OA.

  3. To assess proprioception in knee of healthy individual (without knee pain).

  4. To compare proprioception in affected knee of patient with knee OA with unaffected knee and with healthy individual.

PROCEDURE

• Study will be conducted in the physiotherapy OPD of tertiary care hospital. The study will begin after approval from Departmental Review Board and Institutional Ethics Committee (IEC).

• Patients and controls will be selected according to the inclusion criteria and a written consent will be obtained.

• Control subjects would be patient relatives or patients who do not have knee OA (Whose knee x-rays are negative for knee OA).The cost of x-ray will be borne by me.

• Once consent is obtained, ICD will be signed, retained by the principal investigator and a copy of ICD will be given to the participant.

• Each participant will participate in a single testing session and will be given a information sheet to know the details of the study.

• The case record form which includes demographic data and details will be obtained and filled. The process is explained below. Data will be obtained from the subjects within the age group of 40-60 years seen during their first evaluation of knee pain at our OPD of tertiary care hospital.

• Study design will be observational study.

• Proprioception assessment will be done in non-weightbearing position (i.e.in high sitting).

• With the help of Universal Goniometer.

• Subject will be made sit with legs out of the plinth and thigh fully supported.

• To obtain proper readings of knee angle, the goniometer will be tie to the leg with the help of Velcro straps.

• Fulcrum of the goniometer will be placed on lateral knee joint line, stationary arm will be parallel to line joining greater trochanter to fulcrum and movable arm will be place parallel to line joining fulcrum and  lateral malleolus.

• Then leg will be place at three different angles (30º,45º,60º) very slowly and hold for 5 seconds at each angle to identify the position and will ask them to remember the target positions.

• Then returns to starting position, passively.

• After that subject will be blindfolded to avoid visual cues.

• Then subject will be asked to place leg at varies angle randomly, which was shown earlier, at every angle three readings will be taken.

• For every reading the difference between actual leg position and target position angle will be recorded.

• Mean of the readings will be calculated and recorded as patient’s joint position error (JPE).

• First reading will be taken from affected leg then from unaffected leg and finally it will be taken from control groups individuals.

• Comparison between affected and unaffected, unaffected and control group individuals will be done.

• Data will be collected and subjected to normality test. If the test passes the normality value parametric test will be done and if not pass then non parametric test will be done.

DATA MANAGEMRNT AND ANALYSIS PROCEDURE:

All the data obtained from the participants will be kept confidential. Both hard and soft copy will be maintained. The data will be stored in excel sheets for analysis. Data will be checked for normality, for normally distributed data parametric test will be used. When patient’s affected knee compares with unaffected knee for joint position sense error (JPS), then Paired t-Test will be used.

When unaffected knee of patient compares with knee of normal individual for joint position sense error (JPS), then Unpaired t-Test will be used.

If data does not pass normality test, then non-parametric test such as Mann-Whitney U Test or Wilcoxon signed rank test will be used. SPSS software will be used for analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Individuals in the age group of 40-60 years.
  • Male and female patient with a chronic knee OA.
  • Kellgren-Lawrence grades 1-3 on knee radiograph.
  • Willing to participate.

排除标准

  • Knee surgery within last 12 months.
  • Any neuromuscular or vascular disorder of lower limb.
  • Diabetes Mellitus.
  • Deformity of hip, ankle, back, knee or either knee trauma during last 3 months.

结局指标

主要结局

Proprioception (joint position sense error)

时间窗: 6 months

Difference between actual leg position and target leg position.

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Bharati Asgaonkar

Topiwala National Medical College and B.Y.L. Nair Charitable Hospital

研究点 (1)

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