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临床试验/CTRI/2024/12/078340
CTRI/2024/12/078340尚未招募不适用

Effect of Video assisted Physiotherapy on compliance and functional ability in patients with JIA: A randomized controlled trial

未提供2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
122
试验地点
2
主要终点
compliance rate

研究概览

简要总结

JIA patients typically have follow-ups every three months in the Pediatric Rheumatology Clinic (PRC), making it difficult to assess the compliance to exercise protocol more frequently. This limits direct observation and reinforcement of physiotherapy techniques. To address these challenges, this study explores the use of exercise videos that could mimic direct observation of physiotherapy. This study focuses on compliance to physiotherapy protocol using smartphone/mobile based exercise videos compared to compliance with standard home based exercise protocol. All patients visiting the outpatient department/Pediatric Rheumatology Clinic with diagnosis of JIA, fulfilling the inclusion criteria will be enrolled in the study after proper information and obtaining informed consent from the parents/legally authorized representative (LAR). Assent will be obtained from children >7 years of age. Patients will be divided into two groups: Intervention group (video assisted and routine physiotherapy) and Control group (routine physiotherapy).

Children randomized to intervention group will be taught routine physiotherapy for the affected joints along with which videos of the same will be provided to them. They will be asked to send videos of the exercises daily for the first 7 days. The videos will be assessed by an assessor.  If more than 80% steps are performed correctly according to the check-list, then it will be rated as correct. If the technique is found to be inappropriate it will be corrected on the same day by telephonic call or video call. In case the participant fails to send the videos for 2 consecutive days in the initial 7 days, he/she will be reminded telephonically for the same. After 7 days, participants will send the videos once a week for the next 3 weeks of the first month and then once a month for the remaining 8 months. The patient will be assessed by the two assessors (one of which being an independent assessor) after every 3 months, 6 months and 9 months for the correctness of the technique. They will be reviewed for the functional ability at the end of the study.

Children randomized to control group will continue physiotherapy as usual and be followed up in Pediatric Rheumatology clinic every 3 monthly for 9 months. They would be assessed for correctness of technique and functional ability.

Both the groups will be provided with a diary to record the number of times exercises performed and duration of their daily physiotherapy sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with JIA.

排除标准

  • Non availability of a smart phone/ video capturing device/ internet service
  • Active arthritis within last 15 days
  • Pre-existing deformity of more than 2 joints.

结局指标

主要结局

compliance rate

时间窗: end of 9 months

次要结局

  • functional ability(end of 9 months)
  • Technique of exercises(after every 3 months for the period of study)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Sumita Gupta

AIIMS, New Delhi

研究点 (2)

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