Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

Study Overview
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Brief Summary
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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

Official Title
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A Mobile App for Postural Alignment Exercises in Cervical and Thoracic Spine Regions: Design, Development, Usability and Randomized Controlled Pilot Study

Conditions
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Development and Design of Mobile App, Preventive Physiotherapy, Exercise Adherence, Cervical and Thoracic Spine

Intervention / Treatment
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* Other: App-based group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phase1: Design and development<br>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). | |
| No Intervention: Phase 2: Testing the app<br>We tested the prototype version app interface in the 2nd phase. All participants downloaded the prototype app and used the app for one week. | |
| No Intervention: Phase 3: Usability evaluation<br>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. | |
| Active Comparator: Phase 4: Pilot randomized controlled trial/ The app-based group<br>The app-based group: Participants in the intervention group received their smartphone-based- home exercise program. | Other: App-based group<br>* Participants received home exercise programs by a postural alignment exercise mobile app we developed. The postural alignment app included 3 main emerged themes were recorded as self-assessment, neck/shoulder, and upper back-specific exercise content, and motivational notifications. Participants can evaluate themselves in the application thanks to the self-assessment, receive motivational notifications during the day, and exercise reminders on the days determined by them. They can apply the exercise program with the formed exercise content videos. The exercise program consists of combined exercises that postural alignment plus exercises of neck spinal stabilization, stretching, and strengthening of neck/shoulders/upper back regions. Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.<br>|
| Experimental: Phase 4: Pilot randomized controlled trial/ The control group<br>The control group: Participants in the control group received their home exercise programs as a paper handout. | Other: Control group<br>* Participants received home exercise programs as a paper handout. The exercise program was the same for app-based and control groups. Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of musculoskeletal problems | 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. | Baseline | 
| VAS | 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). | Baseline and at end of the 6 weeks | 
| Neck Pain and Disability Scale | 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)]. | Baseline and at end of the 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of exercise adherence | The app automatically gathers total usage status (count of participated sessions, usage times) when participants login to the app to start an exercise program. Exercise adherence was measured with a ratio of total participated sessions compared with the target defined. | At end of the 6 weeks | 
| Evaluation of app satisfaction | Users were evaluated to rate their satisfaction with the intervention on a 5-point Likert scale after 6 weeks period. | At end of the 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth; Postural alignment; Preventive physiotherapy; Exercise adherence; Neck pain; Upper back pain