Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change of WOMAC Questionnaire from baseline to 24 weeks
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.
排除标准
- •Different diagnosis from hip osteoarthritis (eg. Fracture)
- •Concomitant osteoarthrosis of the hip or knee with gait restrictions
- •Lameness for more than six months
- •Central nervous system or Peripheral nervous system disorders
- •Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
- •Systemic infectious disorders
- •Cognitive impairment
- •Neoplastic disorders
- •Surgical revisions
- •Intraoperative complications
- •Suspected hip replacement infection
- •Hip replacement with endoprosthesis.
结局指标
主要结局
Change of WOMAC Questionnaire from baseline to 24 weeks
时间窗: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).
次要结局
- Change of parameters of Gait Analysis from baseline to 24 weeks(baseline, 1 week, 8 weeks, 16 weeks, 24 weeks)
- Change of Barthel Index from baseline to 24 weeks(baseline, 1 week, 8 weeks, 16 weeks, 24 weeks)
- Change of Visual Analogue Scale (VAS) from baseline to 24 weeks(baseline, 1 week, 8 weeks, 16 weeks, 24 weeks)
- Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks(baseline, 1 week, 8 weeks, 16 weeks, 24 weeks)
- Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks(baseline, 1 week, 8 weeks, 16 weeks, 24 weeks)
研究者
Teresa Paolucci
medical director
University of Roma La Sapienza