Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

NCT ID: NCT04784793

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-11-01

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

App-based group

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Control group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University, Scientific Research Projects Committee

UNKNOWN

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eda Tonga, PHD

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 25931684 (View on PubMed)

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.

Reference Type RESULT
PMID: 32442143 (View on PubMed)

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.

Reference Type RESULT
PMID: 28729234 (View on PubMed)

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.

Reference Type RESULT
PMID: 31304380 (View on PubMed)

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.

Reference Type RESULT
PMID: 27890121 (View on PubMed)

Other Identifiers

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09.2018.069

Identifier Type: -

Identifier Source: org_study_id

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