Additive Effect Of Immersive Virtual Reality Program Along With Conventional exercise On Pain, Function, and Kinesiophobia in Patients with Frozen Shoulder: A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
This document outlines a research proposal for a randomized controlled trial to study the additive effect of immersive virtual reality (IVR) programs combined with conventional exercises on patients with frozen shoulder. Here are the key points:
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Study Design: Randomized controlled trial with two groups - experimental (IVR + conventional exercises) and control (conventional exercises only).
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Population: Patients diagnosed with frozen shoulder, aged 40-60 years.
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Sample Size: 18 participants per group, with a 20% dropout allowance.
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Duration: 6 weeks of intervention, with follow-ups at 12 and 24 weeks.
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Intervention:
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Experimental group: IVR exercises + conventional exercises
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Control group: Conventional exercises only
- Outcome Measures:
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Primary: Shoulder Pain and Disability Index (SPADI)
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Secondary: Numerical Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK-11), Range of Motion (ROM) measurements
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IVR Program: Three phases over 6 weeks, including exercises like penguin picking, fruit catch, and boxing simulations.
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Conventional Exercises: Include active ROM exercises, stretching, joint mobilization, and strengthening exercises.
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Statistical Analysis: Will use SPSS software for data analysis, including tests for normality and appropriate parametric or non-parametric tests.
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Ethical Considerations: Informed consent, confidentiality, and right to withdraw are addressed.
The study aims to provide evidence on the efficacy of immersive virtual reality in treating frozen shoulder, specifically its effects on pain, function, and kinesiophobia, with long-term follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Frozen shoulder patients with Stage 2 and 3, where stiffness is more than pain.
- •NPRS would be between 3 to 7 out of
- •Restriction of PROM would be more than 50% in abduction, flexion, and external rotation.
- •Tampa Scale of Kinesiophobia-11 will be more than 23.
排除标准
- •Proximal humerus fracture to the affected shoulder.
- •Rotator cuff tear.
- •Subacromial bursitis.
- •Rheumatoid Arthritis of the shoulder.
- •Cervicogenic shoulder pain.
- •Pseudo-frozen shoulder.
- •Locked posterior shoulder dislocation.
- •Proximal humerusbony tumor.
- •People who received additional pain management procedures, such as intra-articular injection during the therapy.
- •Surgical intervention on the affected shoulder for 6 months.
- •Unhealed scar around the shoulder.
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline, 6th week, 12th week, 24th week
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline, 6th week, 12th week, 24th week)
- TAMPA Scale of Kinesiophobia (TSK-11)(Baseline, 6th week, 12th week, 24th week)
- Universal Goniometer measurement(Baseline, 6th week, 12th week, 24th week)
- Hand behind-back measurement(Baseline, 6th week, 12th week, 24th week)
研究者
Heti Jadav
Institute of Physiotherapy, Srinivas University