Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Knee joint biomechanics during walking
研究概览
简要总结
Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.
In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.
The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged above 40
- •Self-reported knee-related walking disability
- •In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit.
- •A body mass index (BMI) of ≤35 kg/m2
- •Speaks, reads and writes Danish language
排除标准
- •Usage of Rosehip nutritional supplements within the last 3 months
- •History of symptoms of autoimmune disorders.
- •Planned surgical procedure during the duration of the study
- •History, diagnosis, or signs and symptoms of clinically significant neurological disease
- •Alcohol or drug abuse within the last 5 years
- •History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
- •Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
- •Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.
结局指标
主要结局
Knee joint biomechanics during walking
时间窗: 12 weeks
3-D kinematic gait data is obtained using a 6-camera Motion Analysis System sampling at 100 Hz capturing positions and movements of reflective markers placed on the skin and arranged in the Plug-in-Gait configuration. Ground reaction forces and moments are obtained with two 6-channel force platforms (Advanced Mechanical Technologies, Inc., Newton, MA, USA) operating at 1500 Hz synchronized with the camera system. Specialized software is used to generate lower extremity angular kinematic and kinetic data using inverse dynamics.
次要结局
- Circulating levels of C-reactive protein (blood samples)(12 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(week 12)
- Physician global assessment of patient disease(week 12)
- Self-reported status of the participants' knee and associated problems(week 12)
- Self-reported health and well-being(week 12)
- Circulating levels of Alanine AminoTransferase (blood samples)(12 weeks)
- Circulating levels of Alkaline Phosphatase (blood samples)(12 weeks)
研究者
Marius Henriksen
Senior Researcher
Frederiksberg University Hospital