Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

Exercise Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784793
• Other study ID #: 09.2018.069
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: March 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2020
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Cervical and Thoracic Spine
• Development and Design of Mobile App
• Exercise Adherence
• Preventive Physiotherapy

Intervention

Other:
• App-based group
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.
• Control group
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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	Marmara University, Scientific Research Projects Committee

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Slater 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( — View Citation

Stütz T, Emsenhuber G, Huber D, Domhardt M, Tiefengrabner M, Oostingh GJ, Fötschl 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 2 — View Citation

Toelle 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. eCollec — View Citation

Xie 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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