Development and Design of Mobile AppNCT04784793

Postural Alignment Exercise Mobile App for Cervical and Thoracic Spine Regions

A study testing App-based group in people with Development and Design of Mobile App and Preventive Physiotherapy, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Development and Design of Mobile App, Preventive Physiotherapy, Exercise Adherence
What is being tested?: App-based group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Apr 2018to 1 Nov 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University
Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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

Conditions: Development and Design of Mobile App, Preventive Physiotherapy, Exercise Adherence, Cervical and Thoracic Spine
Being tested: App-based group, Control group
Keywords: mHealth; Postural alignment; Preventive physiotherapy; Exercise adherence; Neck pain; Upper back pain
Medical subject headings: Neck Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

App-based groupOther
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 groupOther
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.

Study groups in NCT04784793
Study group	Role	What they receive
Phase1: Design and development	No intervention	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).
Phase 2: Testing the app	No intervention	We 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 intervention	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.
Phase 4: Pilot randomized controlled trial/ The app-based group	Active comparator	The app-based group: Participants in the intervention group received their smartphone-based- home exercise program. Receives: Other: App-based group
Phase 4: Pilot randomized controlled trial/ The control group	Experimental	The control group: Participants in the control group received their home exercise programs as a paper handout. Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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)].
Measured: Baseline and at end of the 6 weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: At end of the 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20181 Nov 2020

First posted5 Mar 2021
Study start1 Apr 2018
Primary completion15 Sep 2018
Study completion1 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Development and Design of Mobile AppStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04784793
Sponsor's protocol ID: 09.2018.069
Status last verified: Mar 2021
First submitted: 28 Feb 2021
Last updated: 5 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Mobile App for Postural Alignment Exercises in Cervical and Thoracic Spine Regions: Design, Development, Usability and Randomized Controlled Pilot Study
ClinicalTrials.gov ID: NCT04784793
Acronym / sponsor ID: 09.2018.069
Conditions: Development and Design of Mobile App, Preventive Physiotherapy, Exercise Adherence, Cervical and Thoracic Spine
Keywords: mHealth; Postural alignment; Preventive physiotherapy; Exercise adherence; Neck pain; Upper back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 15 Sep 2018 (actual)
Study completion: 1 Nov 2020 (actual)
First posted: 5 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Phase1: Design and development	No intervention	–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).
Phase 2: Testing the app	No intervention	–We 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 intervention	–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.
Phase 4: Pilot randomized controlled trial/ The app-based group	Active comparator	Other: App-based groupThe app-based group: Participants in the intervention group received their smartphone-based- home exercise program.
Phase 4: Pilot randomized controlled trial/ The control group	Experimental	Other: Control groupThe control group: Participants in the control group received their home exercise programs as a paper handout.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
App-based groupParticipants 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.	Other	Phase 4: Pilot randomized controlled trial/ The app-based group
Control groupParticipants 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.	Other	Phase 4: Pilot randomized controlled trial/ The control group

Primary outcome

Evaluation of musculoskeletal problems
Time frame: Baseline
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.
VAS
Time frame: Baseline and at end of the 6 weeks
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).
Neck Pain and Disability Scale
Time frame: Baseline and at end of the 6 weeks
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)].

2 secondary outcomes

Evaluation of exercise adherence
Time frame: At end of the 6 weeks
Evaluation of app satisfaction
Time frame: At end of the 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Results publication: PubMed 25931684Kim 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.
Results publication: PubMed 32442143Slater 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.
Results publication: PubMed 28729234Stutz 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.
Results publication: PubMed 31304380Toelle 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.
Results publication: PubMed 27890121Xie 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eda Tonga, PHD study director

Marmara University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing App-based group in people with Development and Design of Mobile App and Preventive Physiotherapy, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of musculoskeletal problems (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784793, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.