Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever

Официальное название

Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation on Fatigue and Functional Capacity in Juvenile Familial Mediterranean Fever Patients

Обзор

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.

Вмешательства

• Поведенческое Synchronous exercise program
  The synchronous exercise group will be conducted online with synchronous supervision under the supervision of a physiotherapist. The exercise program will be performed for 8 weeks, 2 days a week. In the exercise program, 3 sets, 8 repetitions in 1 set will be progressed to 10-12-15-20-25 repetitions according to tolerance. There will be a 1-2 minute rest between sets.
• Поведенческое Asynchronous exercise group
  The Asynchronous Exercise Group will be conducted with a video-based structured exercise program. For the asynchronous video-based group, a closed channel will be created on Youtube that only patients can access, and the exercises will be uploaded to the system asynchronously. In the asynchronous exercise group, how each exercise is performed will be shown in detail by the physiotherapist in the video content.

Первичные конечные точки

• Visuel Analog Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks"]
• Six Minute Walking Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (12)

• PedsQL Multidimensional Fatigue Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Fatigue Severity Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• 30 Second Sit-to-Stand Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• 10-Step Climbing Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Half Squat Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Pacer Run Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Single Leg Stand Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Functional Forward Reach Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• K- Force-Kinvent Measurement and Evaluation Set [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Digitsole Pro Smart Insole System [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• FitnessGram Test Battery- Sit-up test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• FitnessGram Test Battery-The push-up test [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
• Acute pain for any reason
• Development of amyloidosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University-Cerrahpasa — Istanbul

Идентификаторы

NCT: NCT06743152 · ANamli

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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