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临床试验/NCT05501184
NCT05501184已完成不适用

COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION

Marmara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Numerical Pain Rating Scale (NPRS)

研究概览

简要总结

This was a randomized controlled trial conducted to examine the changes in the pain, physical function, quality of life, and kinesiophobia of participants with non-specific neck pain in Marmara University Physiotherapy and Rehabilitation Department. This study was approved by the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in January 2022 and was carried out in accordance with the Declaration of Helsinki. The participants were informed about the study and their consent was obtained.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants between the ages of 18-65,
  • •Who had access to the internet and smartphone,
  • •Had the ability to conduct video calls were included in the study.

排除标准

  • •Participants were excluded if they had COVID-19,
  • •Had surgery in the last 6 months,
  • •Received physiotherapy treatment.
  • •Had a condition that prevented them from exercising.

研究组 & 干预措施

Synchronous Telerehabilitation Group

Experimental

The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.

干预措施: Synchronous Exercise Program (Other)

Asynchronous Telerehabilitation Group

Active Comparator

The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.

干预措施: Asynchronous Exercise Program (Other)

结局指标

主要结局

Numerical Pain Rating Scale (NPRS)

时间窗: The pain was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.

Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.

次要结局

  • Neck Disability Index (NDI)(The disability was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.)
  • Cervical Mobility(The cervical mobility was measured at baseline and at the end of treatment in the 8th week.)
  • Tampa Scale of Kinesiophobia (TSK)(The kinesiophobia was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.)
  • Short Form-36 (SF-36)(The quality of life was measured at baseline and at the end of treatment in the 8th week.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eren Timurtas

PhD

Marmara University

研究点 (1)

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