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临床试验/NCT05704023
NCT05704023已完成不适用

Effects of a Mobile App on Adherence to Daily Exercise and Recovery After Whiplash Injury - a Randomized Controlled Trial

Blaz Barun2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Change in Neck Disability Index from baseline to 6 months after the injury

研究概览

简要总结

This study investigates the effect of daily mobile app reminders to exercise in conjunction with standard physical therapy on adherence to exercise and recovery after whiplash injury of the neck. Participants will be divided into two groups, the experimental (Arm A) and control group (Arm B). Both groups will complete a standard physical therapy program under the supervision of a physiotherapist. Both groups will get illustrated home exercise programs and will be advised to continue exercising at home. In addition, the experimental group will receive one daily push notification via a mobile app to perform a daily exercise at home.

详细描述

Whiplash injury of the neck is the most common injury resulting from a traffic accident. Although most people recover completely, 30 to 50% of them develop chronic neck pain and disability. Also, long sick leaves and lower productivity at work create a burden on the healthcare system.

Conservative treatment includes exercise, physical therapy modalities such as transcutaneous electric nerve stimulation (TENS), and ultrasound therapy. Although conservative treatment is recommended, the evidence of its efficacy remains unclear. Education after the injury can be beneficial in lowering anxiety and pain.

Many studies are investigating the usefulness of mobile apps in various medical conditions. In rehabilitation medicine, apps are used to increase knowledge about different conditions, as a measurement tool, and as an intervention to increase adherence to the prescribed therapy.

After the enrollment in the study, participants will complete the two-part physical therapy program (2x10 sessions, 5times/day, 3-week break in between) under the supervision of a physiotherapist at the outpatient clinic. After completing the program, the participants will get a home exercise program, group A via mobile app, and group B via papers, and will be encouraged to continue exercising at home. Also, group A will download a mobile app, "WIapp," that was developed for this purpose and will receive one daily push notification as a reminder to perform a daily exercise at home.

The investigators hypothesize that daily reminding to exercise via mobile app can increase adherence to prescribed therapy and overall increase recovery.

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 (Care Provider)

入排标准

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

入选标准

  • patients who sustained whiplash injury of the neck in a car accident as drivers or co-drivers
  • diagnosed with a whiplash injury of the neck by physical and rehabilitation medicine specialist within 3 months
  • Neck Disability Index (NDI) score higher than 5 (10%)
  • possession of and ability to use a smartphone and a mobile app
  • age ≥ 18 years
  • signed written informed consent

排除标准

  • bone fracture sustained in the accident
  • spinal cord injury
  • accident in any other type of vehicle other than car
  • treatment of malignant disease in the last 5 years
  • expected non-compliance (not possible to use a smartphone because of severe mental or physical impairment)

结局指标

主要结局

Change in Neck Disability Index from baseline to 6 months after the injury

时间窗: baseline, 6 months after the injury

Physical functioning - where values from 0-8% are regarded as no disability, 10-28% mild disability, 30-48% as moderate disability, 50-68% severe disability, and 70-100% complete disability)

次要结局

  • Questionnaire assessment of adherence to exercise(6 months after the injury)
  • Questionnaire assessment of perceived recovery(6-months after the injury)
  • Questionnaire assessment work(baseline, 6 months after the injury)
  • Pain catastrophizing scale(6 months after the injury)
  • Short Form Health Survey 12(6 months after the injury)
  • Change in Visual Analog Scale (VAS) Pain Score from baseline to 6 months after the injury(baseline, 6 months after the injury)
  • Questionnaire assessment of social functioning(6 months after the injury)

研究者

发起方
Blaz Barun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Blaz Barun

Principal Investigator

University of Split, School of Medicine

研究点 (2)

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