Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions
A Mobile App for Postural Alignment Exercises in Cervical and Thoracic Spine Regions: Design, Development, Usability and Randomized Controlled Pilot Study
1 other identifier
interventional
40
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 28, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedMarch 5, 2021
March 1, 2021
6 months
February 28, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Evaluation of exercise adherence
At end of the 6 weeks
Evaluation of app satisfaction
At end of the 6 weeks
Study Arms (5)
Phase1: Design and development
NO INTERVENTIONWe 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
NO INTERVENTIONWe 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
NO INTERVENTIONWe 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
ACTIVE COMPARATORThe app-based group: Participants in the intervention group received their smartphone-based- home exercise program.
Phase 4: Pilot randomized controlled trial/ The control group
EXPERIMENTALThe control group: Participants in the control group received their home exercise programs as a paper handout.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Istanbul, Turkey (Türkiye)
Related Publications (5)
Kim HJ; DH; Kim JS. The relationship between smartphone use and subjective musculoskeletal symptoms and university students. J Phys Ther Sci. 2015 Mar;27(3):575-9. doi: 10.1589/jpts.27.575. Epub 2015 Mar 31.
PMID: 25931684RESULTSlater H, Stinson JN, Jordan JE, Chua J, Low B, Lalloo C, Pham Q, Cafazzo JA, Briggs AM. Evaluation of Digital Technologies Tailored to Support Young People's Self-Management of Musculoskeletal Pain: Mixed Methods Study. J Med Internet Res. 2020 Jun 5;22(6):e18315. doi: 10.2196/18315.
PMID: 32442143RESULTStutz T, Emsenhuber G, Huber D, Domhardt M, Tiefengrabner M, Oostingh GJ, Fotschl U, Matis N, Ginzinger S. Mobile Phone-Supported Physiotherapy for Frozen Shoulder: Feasibility Assessment Based on a Usability Study. JMIR Rehabil Assist Technol. 2017 Jul 20;4(2):e6. doi: 10.2196/rehab.7085.
PMID: 28729234RESULTToelle TR, Utpadel-Fischler DA, Haas KK, Priebe JA. App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial. NPJ Digit Med. 2019 May 3;2:34. doi: 10.1038/s41746-019-0109-x. eCollection 2019.
PMID: 31304380RESULTXie Y, Szeto G, Dai J. Prevalence and risk factors associated with musculoskeletal complaints among users of mobile handheld devices: A systematic review. Appl Ergon. 2017 Mar;59(Pt A):132-142. doi: 10.1016/j.apergo.2016.08.020. Epub 2016 Sep 11.
PMID: 27890121RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eda Tonga, PHD
Marmara University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2021
First Posted
March 5, 2021
Study Start
April 1, 2018
Primary Completion
September 15, 2018
Study Completion
November 1, 2020
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share