Clinical and Instrumental Biomechanical Assessement and Rehabilitation of Patients With Knee Osteoarthritis:A Randomized Single Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
A randomized clinical trial to evaluate the effectiveness of an instrumental rehabilitation protocol compared with standard protocol In patients with knee osteoarthritis.
详细描述
This is a randomized clinical trial designed to compare two intervention aimed at reducing and improving knee function in patients with knee osteoarthritis
- sixty subjects suffering from knee osteoarthritis will be recruited; 30 per group.
A: instrumental rehabilitation B:standard rehabilitation All patients who meet the clinical inclusion and exclusion criteria will have a standard radiography
- selected patients will be invited to participate and will be informed of the purpose and conduct of the study
- patients will be randomized to either the instrumental rehabilitation programme groupe or the standard rehabilitation group
- patients in both groups will have a protocol that will be extended over 6 weeks
- participants will be assessed primarily for function and pain, as well as other secondary endpoints , at baseline at 3 weeks and at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Masking is a technique used to keep treatment information indisclosed to the study participants while allowing researchers and treatment administration to know this information: study participants are not informed about the treatment they are receiving, they do not know whether they are receiving the experimental treatment under investigation or if they are in the control group , which may receive a placebo or standard treatment .
This helps reduce potential bias related to participant expectations
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with radiologically confirmed uni/ bilateral gonarthrosis
排除标准
- •Will be excluded from our study:
- •Subjects with congestive gonarthrosis (joint effusion at clinical examination).
- •Patients followed for chronic inflammatory rheumatism.
- •Patients who are candidates for surgery for knee osteoarthritis
- •Patients with a pathology causing a limitation in walking distance apart from gonarthrosis.
- •Amputees of one or both lower limbs.
结局指标
主要结局
Le Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 12 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is an assessment tool developed to measure pain, stiffness, and physical function in individuals with osteoarthritis, primarily in the knee and hip. Patients' responses to each question are typically scored on a scale ranging from 0 to 4, where 0 signifies "no symptoms" and 4 signifies "severe symptoms." Scores obtained in each subscale can be combined to provide a total score or used individually to assess specific aspects of osteoarthritic symptoms.
次要结局
- quality of life index(12 weeks)
- muscle testing of hamstring and quadriceps(12 weeks)
- time up and go(12 weeks)
- Joint amplitude measurements(12 weeks)
- the Visual Analog Scale(12 weeks)
- walking test(12 weeks)
- results of balance plateform assessement(12 weeks)
- muscle testing of hamstring and quadriceps using an isokinetic dynamometer(12 weeks)
研究者
EL Moudane Houda
principal Investigator
Mohammed V Souissi University