Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Visuel Analog Scale
研究概览
简要总结
Our study will be randomized controlled. Familial Mediterranean Fever patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. The first group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist, and the second group will be applied an asynchronous video-based exercise program. The exercise program will be carried out for 8 weeks, 2 days a week. There will be 3 sets, 8 repetitions in 1 set in the exercise program and will be progressed according to tolerance. In the exercise program, the synchronous group will perform the exercises with the supervision of a physiotherapist via the Zoom application, while the asynchronous video-based group will upload the exercises to the system asynchronously via a channel on YouTube that only patients can access. Feedback will be received from the asynchronous group by phone. Our exercise program will be organized with the progression of exercises such as squat, lunge, stepping, running in place and jumping. The primary outcome measures of the study are the evaluation of fatigue (VAS) and functional capacity (6-Minute Walking Test). Our secondary outcome measures are the evaluation of pain, balance, physical fitness and walking. For the assessment of fatigue: Visual Analog Scale (VAS), PedsQL Multidimensional Fatigue Scale, Fatigue Severity Scale; For the assessment of functional capacity: 6 Minute Walk Test, 30 sec Sit-to-Stand Test, 10-Step Climbing Test, Pacer aebonic fitness test, Half Squat Test; For the assessment of balance: One-Leg Stand Test, Functional Forward Reach Test, Kinvent (K-plate)-K Force measurement evaluation set, Digitsole Smart Insole System for the assessment of walking; For the assessment of physical fitness: FitnessGram test battery; For the assessment of pain: VAS will be used.
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 (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 12-18
- •The parent's willingness to have their child participate in the study
- •Being diagnosed with FMF at least 6 months ago
- •Being in an attack-free period
- •Have an internet access
- •Being able to use a computer, tablet or smartphone
- •Have access to a technological device with a camera, microphone and speaker output
- •Being willing to participate in the study
排除标准
- •Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
- •Acute pain for any reason
- •Development of amyloidosis
结局指标
主要结局
Visuel Analog Scale
时间窗: From enrollment to the end of treatment at 8 weeks"
In the evaluation of patient fatigue, patients will be asked to mark on a 100 mm horizontal line. According to VAS, a 0 mm point on this line indicates no fatigue, while a 100 mm point indicates very severe fatigue.
Six Minute Walking Test
时间窗: From enrollment to the end of treatment at 8 weeks
It is a test frequently used to evaluate functional capacity. The distance that patients walk in a 30-meter corridor on a flat surface for 6 minutes will be recorded.
次要结局
- PedsQL Multidimensional Fatigue Scale(From enrollment to the end of treatment at 8 weeks)
- Fatigue Severity Scale(From enrollment to the end of treatment at 8 weeks)
- 30 Second Sit-to-Stand Test(From enrollment to the end of treatment at 8 weeks)
- 10-Step Climbing Test(From enrollment to the end of treatment at 8 weeks)
- Half Squat Test(From enrollment to the end of treatment at 8 weeks)
- Pacer Run Test(From enrollment to the end of treatment at 8 weeks)
- Single Leg Stand Test(From enrollment to the end of treatment at 8 weeks)
- Functional Forward Reach Test(From enrollment to the end of treatment at 8 weeks)
- K- Force-Kinvent Measurement and Evaluation Set(From enrollment to the end of treatment at 8 weeks)
- Digitsole Pro Smart Insole System(From enrollment to the end of treatment at 8 weeks)
- FitnessGram Test Battery- Sit-up test(From enrollment to the end of treatment at 8 weeks)
- FitnessGram Test Battery-The push-up test(From enrollment to the end of treatment at 8 weeks)
- FitnessGram Test Battery-The Sit-Reach test(From enrollment to the end of treatment at 8 weeks)
- FitnessGram Test Battery-The trunk lift test(From enrollment to the end of treatment at 8 weeks)
- FitnessGram Test Battery- body composition(From enrollment to the end of treatment at 8 weeks)
- Visuel Analog Scale(From enrollment to the end of treatment at 8 weeks)
研究者
Aysenur Namli
MSc
Istanbul University - Cerrahpasa