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临床试验/CTRI/2024/10/075313
CTRI/2024/10/075313尚未招募2/3 期

Effectiveness of Immersive Virtual Reality Based Exercises on pain,Proprioception and Function in subjects with osteoarthritis of knee

Vaheedha S1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
1.Joint Propriocpetion Test, 2.WOMAC,

研究概览

简要总结

INTRODUCTION:

Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders and represents a major cause of debilitation in affected individuals, The age of respondents ranged from 18–80 years, with a mean of 35 ± 13.11 (Omar W. Athomali et.al, 2005) In people aged was Approximately to worldwide (3.6% of population have knee osteoarthritis) 36,000/Million, Knee OA is the most common form of arthritis associated with functional impairment in middle aged and elder people, There is potential association between impaired knee proprioception and pathological changes during early stages of knee OA (Bennell KL et al 2003),There are several therapies including the recent technological interventions such as AI and VR for OA. VR Is a novel technology defined as “the use of interactive simulations created with computer hardware and software to present users with opportunities to engage in environment that appear to be a feel a similar to real-world objects and events, The contribution of vision and proprioception to retrieving information about own body location and movement at different stages of remembering i.e., encoding, storage and recall phases. Understanding this complex relationship is crucial for development of technologies that facilitate human navigation and to inform motor rehabilitation programme in patients with Knee OA (KOA), weakening and damage of the knee muscles, tendons, ligaments, and articular capsule is related to body’s proprioception decreases (Relph and Herrington, 2015).  The weakening and damage of proprioceptors make patients’ pain and perception abnormal could lead to the severe consequence of KOA (Bennell et al., 2003). Weak patients with poor proprioceptors have limited joint functional ability (van der Esch et al., 2007) The repeated proprioceptive training with functional elements increased cumulative neural inputs to the central nervous system via mechanoreceptors and proprioceptors in the joint capsules, ligaments, muscles, tendons, and skin.

NEED FOR THE STUDY: During each stage of osteoarthritis knee, many pathological changes take place the destruction of smooth cartilage that covers the ends of bones, reduction of joint space, and formation of new bone called osteophytes taking place on joint margins. All these changes lead to weakness of muscles around the joint, joint pain, Proprioceptive deficits, decreased physical functional activities of individuals, balance disturbances, etc. The study on virtual reality-based exercises in osteoarthritis (OA) knee treatment is crucial to address the growing need for innovative and patient-centric approaches in healthcare.

OBJECTIVES

Ø To find the effectiveness of immersive virtual reality-based exercises on physical function in subjects with osteoarthritis of the knee.

Ø To find the effectiveness of immersive virtual reality-based exercises on the range of motion in subjects with osteoarthritis of knee.

Ø To find the effectiveness of immersive virtual reality-based exercises in measuring the Pain in subjects with osteoarthritis of the knee.

Methodology:

A total of 64 patients will be Recruited with unilateral osteoarthritis of knee based on selection criteria. Informed Consent and information sheet will be explained on obtained from all participants with their voluntary consent. Included participants will be The pre-participation evaluation form such as range of motion, numerical pain rating scale, womac questionarie, joint proprioception test after completion of the pre-test participants will be allocated into two groups by the concealed envelope method. Experimental group will be receiving virtual reality-based exercises along with conventional exercises, Laser and Control group both groups will be treated for 4 weeks 5 repetitions of 4 weeks

Stastical analysis:

Sample size calculated for 80% Population Proportion, 95% Confidence Interval, and 9% Margin Error for both experimental and control group samples will be allocated through concealed envelop as 32 in each group. Stastical analysis will be performed using Mann-Whitney U test for between- groups Comparison and Wilcoxon Test for within- groups comparisons

Excepted outcomes:

The primary excepted outcomes of the study include significant improvements in pain, functional outcome, proprioception, range of motion. Additionally, enhanced functional activity and proprioception post intervention is anticipated.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Unilateral Knee joint involvement.
  • NPRS less than 7 Points 3.Based on 3 to 4 categories of KELLGREN AND LAWRENCE, having at least 6months of knee pain.
  • 4.Both male and female subjects.

排除标准

  • Any Recurrent knee injury, such as Tendon or Ligament Tear
  • Patients history of traumatic injury and surgery of knee joint
  • Unstable health conditions like heart, lung conditions
  • Patients unable to walk independently systemic and psychiatric illness
  • Open wounds any ulcers in the foot or skin
  • Patients with Deep sensation impairement.

结局指标

主要结局

1.Joint Propriocpetion Test, 2.WOMAC,

时间窗: 4 weeks

3.NPRS

时间窗: 4 weeks

次要结局

  • 4.Range of Motion(4 weeks)

研究者

发起方
Vaheedha S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vaheedha s

Saveetha College of Physiotherapy,Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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