A Mobile App for Postural Alignment Exercises in Cervical and Thoracic Spine Regions: Design, Development, Usability and Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of musculoskeletal problems
研究概览
简要总结
Postural alignment in the cervical and thoracic regions is affected by various risks such as smartphone use in particular young adults. The small screen of smartphones causes ergonomic risk for posture and musculoskeletal system. Previous studies found that neck, shoulder, and upper back pain associated with the overuse of smartphones. Neck pain often arises from unideal postures. Participants should be informed about these risks and encouraged to exercise to be protective. Digital health apps' use is rising by the day and health apps offer opportunities for both healthcare professionals and users.
Therefore, this study aimed to develop an app including preventive exercise interventions to keep postural alignment in cervical and thoracic spine regions employing an iterative, user-centred design and to test the usability of the app and evaluate its effectiveness with a pilot randomized controlled trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to be a university student aged 18-25, to be a smartphone user for more than 3 years with more than three hours daily use.
排除标准
- •if they had any chronic health problems (rheumatic, orthopedic, neurological, cardiopulmonary, vestibular system), any trauma in the neck/upper back/upper limb region in the last six months, had a congenital deformity, had received another treatment or having surgery in last one year.
研究组 & 干预措施
Phase1: Design and development
We conducted focus group meetings to discuss the content, features and design of the app.
The focus group consisted of physiotherapists and young adults. The focus group members discussed the variety of topics in subgroups (login parameters, self-monitoring, exercises content, video or animation types, exercise diary, reminders, encouragement, method, etc).
Phase 2: Testing the app
We tested the prototype version app interface in the 2nd phase. All participants downloaded the prototype app and used the app for one week.
Phase 3: Usability evaluation
We conduct a think-aloud interview and evaluate the quantitative usability in the third phase.
The quantitative usability was assessed by the System Usability Scale (SUS), and the adapted Usability, Satisfaction and Ease to Use (USE) Questionnaire.
Phase 4: Pilot randomized controlled trial/ The app-based group
The app-based group:
Participants in the intervention group received their smartphone-based- home exercise program.
干预措施: App-based group (Other)
Phase 4: Pilot randomized controlled trial/ The control group
The control group:
Participants in the control group received their home exercise programs as a paper handout.
干预措施: Control group (Other)
结局指标
主要结局
Evaluation of musculoskeletal problems
时间窗: Baseline
Musculoskeletal problems were assessed by Nordic Musculoskeletal Questionnaire. The Nordic Musculoskeletal Questionnaire queries yes/no for nine body regions so far, in the last 12 months, and in the last 7 days of evaluation, whether ache, pain, or discomfort.
VAS
时间窗: Baseline and at end of the 6 weeks
Neck pain was assessed by Visual Analog Scale (VAS) before and after the 6 weeks exercise program. The participants were instructed to mark a point on a line between zero (no pain) and 10 cm (maximum pain).
Neck Pain and Disability Scale
时间窗: Baseline and at end of the 6 weeks
Functional disability associated with neck pain was evaluated by the Neck Pain and Disability Scale (NPAD) questionnaire before and after the 6 weeks exercise program. The Neck Pain and Disability Scale consists of 20 items and each item was scored from 0 to 5, and the total score is the sum of the item scores \[possible range 0 (no pain)-100 (maximal pain)\].
次要结局
- Evaluation of exercise adherence(At end of the 6 weeks)
- Evaluation of app satisfaction(At end of the 6 weeks)