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CompletedNCT04784793Updated Mar 5, 2021

Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

An interventional study of App-based group and Control group in Development and Design of Mobile App, Preventive Physiotherapy and Exercise Adherence, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by Marmara University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Apr 2018, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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

02

Conditions studied

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

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Keywords

  • mHealth; Postural alignment; Preventive physiotherapy; Exercise adherence; Neck pain; Upper back pain
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    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).

  • No intervention
    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.

  • No intervention
    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.

  • Active comparator
    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.

    Other: App-based group

  • Experimental
    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.

    Other: Control group

Interventions

  • OtherApp-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.

  • OtherControl 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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).

    Time frame: Baseline and at end of the 6 weeks

  3. 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 \[possible range 0 (no pain)-100 (maximal pain)\].

    Time frame: Baseline and at end of the 6 weeks

Secondary outcomes

  1. 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.

    Time frame: At end of the 6 weeks

  2. Evaluation of app satisfaction

    Users were evaluated to rate their satisfaction with the intervention on a 5-point Likert scale after 6 weeks period.

    Time frame: At end of the 6 weeks

07

Study locations

1 site
  • Marmara University
    İstanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 25931684 ↗
  • 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(6):e18315. doi: 10.2196/18315. PubMed 32442143 ↗
  • Stutz 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. PubMed 28729234 ↗
  • 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. eCollection 2019. PubMed 31304380 ↗
  • 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. PubMed 27890121 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04784793
Lead sponsor
Marmara University
Collaborators
Marmara University, Scientific Research Projects Committee
Responsible party
Sponsor
First posted
Mar 5, 2021
Start date
Apr 1, 2018
Primary completion
Sep 15, 2018
Completion
Nov 1, 2020
Last update
Mar 5, 2021

Study contacts

Eda Tonga, PHD
study director · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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