Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Disability (Victorian Institute of Sport Assessment - Patellar)
研究概览
简要总结
Chronic tendinopathies (CT) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. Virtual reality (VR) fosters patient recovery through playful activities that promote competitiveness, stimulates motivation and continuous attention, allows individualizing the exercise program, objectively assessing the execution of the treatment and monitoring the patient's evolution. Therefore, the VIRTENDON-REHAB project aims to conduct a low-risk randomized controlled clinical trial to analyze the efficacy of a VR-based physical rehabilitation program in a population diagnosed with CT on pain, functionality, range of motion, strength, muscle activation pattern, kinesiophobia, quality of life, adherence to treatment and patient satisfaction with the use of the system, compared to a control group. Likewise, the aim is to characterize the clinical profile of this population and to know the relationships between the previous variables. Measurements will be taken at the beginning of the intervention, at the end (12 weeks) and 3 months after the end of the intervention. A descriptive analysis will be performed, inter- and intra-group differences will be analyzed by means of t-Student, Wilcoxon, Mann-Whitney U and mixed ANOVA tests. Cohen's d will be used to determine the effect size. Relationships between variables will be analyzed using structural equations. The results obtained will allow improving knowledge on the management of CT using VR, as well as improving clinical care and reducing healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A single-blind method will be carried out on the persons collecting and analysing the data
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).
- •Duration of symptoms: greater than 6 weeks.
排除标准
- •People who have any pathology that prevents them from performing physical exercise.
- •Persons who have undergone surgery.
- •Persons who have an illness that may be a contraindication to the proposed procedure.
- •Persons who have received exercise therapy in the last 3 months.
- •Persons who have received corticosteroid injections in the last 3 months.
结局指标
主要结局
Disability (Victorian Institute of Sport Assessment - Patellar)
时间窗: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Pain (Visual Analogue Scale)
时间窗: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change from 0 to 10. Higher scores mean worse outcome.
Disability (Shoulder And Pain Disability Index)
时间窗: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change from 0 to 100. Higher scores mean worse outcome.
Disability (Victorian Institute of Sport Assessment - Achilles)
时间窗: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change from 0 to 100. Higher scores mean better outcome.
次要结局
- Quality of Life (36-item Short Form Survey)(From Baseline up to 24 Weeks Follow-up)
- User satisfaction (Consumer Report Effectiveness Scale)(12 Weeks and 24 Weeks)
- Strength (Dynamometer)(Fom Baseline up to 24 Weeks Follow-up)
- Kinesiophobia (Tampa Scale Questionnaire)(From Baseline up to 24 Weeks Follow-up)
- Range of motion (Goniometer)(Fom Baseline up to 24 Weeks Follow-up)
- Adherence (Exercise Adherence Rating Scale)(12 Weeks and 24 Weeks)