Adolescence Idiopathic ScoliosisNCT07686848
Smartphone App for Adolescents With Idiopathic Scoliosis
A study testing DinSkoliose smartphone application in people with Adolescence Idiopathic Scoliosis and AIS, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
This study aims to evaluate a smartphone application (DinSkoliose) designed to support adolescents with idiopathic scoliosis (AIS) in managing their condition and following their treatment. Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Adolescence Idiopathic Scoliosis, AIS
- What is being tested?
- DinSkoliose smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2028to Sep 2031
- Phase
- Interventional
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 10 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
The study population will consist of adolescent patients with AIS.
The Inclusion criteria for participants in our study are those:
- who are diagnosed with AIS;
- who give written informed consent,
- who are at the age between 10 - 24 years old;
- under 16 years old for whom parental consent has been provided (as required by the National Research Ethics Committee);
- who can speak, read, and write in Norwegian or English;
- who have access to and ability to use smart phone;
- who have internet access.
The Exclusion criteria for participants in our study are those who:
- have a history of other type of scoliosis (such as congenital, neuromuscular, degenerative);
- are younger than 10 years old and older than 24 years old;
- have any additional diagnosis that could affect the intervention outcome (severe mental health disorders or diagnosis of a developmental disorder that prevents understanding and compliance with intervention, leg length discrepancy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
OsloMet
Oslo, 0130
Minna Pikkarainen, Professor, 41231716, minnapik@oslomet.no
Kamila Sykorova, Master, 92558497, kasyk0342@osloomet.no
About this study
Official title: Evaluating the Impact of a Smartphone App on Health Outcomes and Treatment Adherence in Adolescents With Idiopathic Scoliosis: A Mixed Method Quasi-Experimental Study
This study aims to evaluate a smartphone application (DinSkoliose) designed to support adolescents with idiopathic scoliosis (AIS) in managing their condition and following their treatment.
Adolescents with AIS often find it challenging to adhere to conservative treatment, such as wearing a brace or performing physiotherapy exercises. The app was developed specifically for this study as a theory-informed digital health intervention to support self-management and treatment adherence. It includes features such as symptom tracking, educational content, reminders, and social support.
Read more
Participants will use the app for 12 weeks in their everyday environment alongside their usual care. They will complete questionnaires before and after the intervention and participate in an interview to share their experiences.
The study will examine whether the app can improve health-related behaviors, including treatment adherence and self-management, and whether it is feasible and acceptable for adolescents with scoliosis.The app is meant to complemen the current AIS treatment, doesn't substitute it.
Read the detailed description
This study is a quasi-experimental, one-group pretest-posttest study designed to evaluate the feasibility, acceptability, and preliminary effectiveness of a smartphone application (DinSkoliose) for adolescents with idiopathic scoliosis (AIS).
AIS is a common spinal condition that often requires long-term conservative treatment, including brace use and physiotherapy scoliosis-specific exercises. Treatment success is highly dependent on adherence; however, adherence is often limited by physical discomfort, psychological factors, and lack of continuous support.
The DinSkoliose app is a personalized, theory-informed digital health intervention developed specifically for this study using a user-centered co-design approach. The app is grounded in behavioral theories of motivation and self-management and includes features to support treatment adherence, such as tracking of brace use and exercises, monitoring of symptoms (e.g., pain and mood), educational information, reminders, and structured social support.
Participants will use the app over a 12-week period in their natural environment alongside their usual care, with no additional clinical intervention. Outcomes will be assessed at baseline and post-intervention using validated questionnaires measuring health behaviors, self-management, self-efficacy, social support, and patient activation. App usability, engagement, and acceptability will also be evaluated.
In addition, semi-structured interviews will be conducted after the intervention to explore participants' experiences and identify strengths and areas for improvement. The results will inform further development of the app and future evaluation in larger controlled studies.
- Conditions
- Adolescence Idiopathic Scoliosis, AIS
- Being tested
- DinSkoliose smartphone application
- Keywords
- scoliosis, app, digital health, treatment adherence, self-determination theory, self-efficacy, social support, theory driven
- Medical subject headings
- Scoliosis, Alzheimer Disease, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinSkoliose smartphone applicationDevice
The intervention consists of the use of the DinSkoliose smartphone application, a personalized digital health tool specifically developed for this study. The app is designed to support adolescents with idiopathic scoliosis in managing their condition and improving adherence to conservative treatment.
The app includes features for monitoring brace use and physiotherapy exercises, tracking symptoms such as pain and mood, providing educational content, sending reminders, and offering structured social support. Participants will use the app independently in their everyday environment over a 12-week period alongside their usual care. No additional treatment will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: DinSkoliose App | Experimental | Participants in this arm will use the DinSkoliose smartphone application for a period of 12 weeks. The app is designed to support adolescents with idiopathic scoliosis in managing their condition by promoting treatment adherence, self-management, and engagement.
The intervention includes features such as treatment tracking (e.g., brace use and physiotherapy exercises), symptom monitoring (e.g., pain, mood, and sleep), educational content, reminders, and access to social support. Participants will use the app in their everyday environment alongside their standard care. Receives: Device: DinSkoliose smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Behaviors Outcome
Change in health behaviour outcomes, including self-management, knowledge, skills, and confidence, measured using the Patient Activation Measure (PAM). PAM is a validated 13-item questionnaire with scores ranging from 0 to 100, where higher scores indicate greater patient activation and improved health behaviour.
Measured: Baseline to 12 weeks
Change in behavioral impact (such as self-management of AIS)
Change in self-efficacy, defined as participants' confidence in their ability to manage their condition, perform health-related behaviors, and cope with symptoms, measured using the Chronic Disease Self-Efficacy Scale (CDSES). Scores range from 1 to 10, with higher scores indicating greater self-efficacy.
Measured: Baseline to 12 weeks
Change in motivation for exercise measured by SDT-based Motivation for Exercise questionnaire
Change in motivation for exercise measured using a Self-Determination Theory (SDT)-based Motivation for Exercise questionnaire, assessing different types of motivational regulation (external, introjected, identified, and intrinsic motivation). Scores reflect the degree of autonomous versus controlled motivation, with higher autonomous motivation indicating more self-determined and sustainable health behaviour.
Measured: Baseline to 12 weeks
Secondary outcomes (4)
User engagement measured by User Engagement Scale (UES)
User engagement measured using the User Engagement Scale (UES), a validated questionnaire assessing multiple dimensions of engagement including focused attention, perceived usability, aesthetic appeal, and reward-related engagement. Responses are rated on a Likert scale, and higher scores indicate greater user engagement with the intervention.
Measured: Week 6 and Week 12
Change in perceived social support measured by Medical Outcomes Study Social Support Survey (MOS-SSS)
Change in perceived social support measured using the Medical Outcomes Study Social Support Survey (MOS-SSS), a validated questionnaire assessing emotional/informational support, tangible support, positive social interaction, and affectionate support. Scores are calculated on a Likert scale, with higher scores indicating greater perceived social support.
Measured: Baseline to 12 weeks
App usability and acceptability measured by Mobile App Rating Scale (MARS)
App usability and acceptability measured using the Mobile App Rating Scale (MARS), which evaluates app quality across multiple domains including engagement, functionality, aesthetics, and information quality. Items are rated on a 5-point scale, with higher scores indicating better app quality and acceptability.
Measured: Week 6 and Week 12
Participant experiences and perceived impact assessed through semi-structured interviews
Participant experiences, perceptions, and perceived impact of the intervention assessed through semi-structured qualitative interviews. Interviews explore app usability, engagement, perceived effects on health behaviour, self-management, and psychosocial well-being. Data will be analyzed using thematic analysis.
Measured: At 12 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startApr 2028 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Adolescence Idiopathic ScoliosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, quasi-experimental study with a pretest-posttest design (no comparator group)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Ryggforeningen i Norge, Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686848
- Sponsor's protocol ID
- 933077
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not yet been determined. Any future data sharing will depend on ethical approvals, data protection regulations, and the feasibility of adequately anonymizing the data, particularly considering the inclusion of qualitative interviews and a relatively small study sample.
Publications
Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
PubMed 30973342Zelmer J, van Hoof K, Notarianni M, van Mierlo T, Schellenberg M, Tannenbaum C. An Assessment Framework for e-Mental Health Apps in Canada: Results of a Modified Delphi Process. JMIR Mhealth Uhealth. 2018 Jul 9;6(7):e10016. doi: 10.2196/10016.
PubMed 29986846Yoo H, Kim CJ, Jang Y, You MA. Self-efficacy associated with self-management behaviours and health status of South Koreans with chronic diseases. Int J Nurs Pract. 2011 Dec;17(6):599-606. doi: 10.1111/j.1440-172X.2011.01970.x.
PubMed 22103826Yin, M., Tayyab, S. M. U., Xu, X. Y., Jia, S. W., & Wu, C. L. (2021). The investigation of mobile health stickiness: the role of social support in a sustainable health approach. Sustainability, 13(4), 1693. https://doi.org/10.3390/su13041693
Wolniak, R. (2017). The Design Thinking method and its stages. Systemy wspomagania w inżynierii produkcji, 6(6), 247-255
Wellburn S, van Schaik P, Bettany-Saltikov J. The Information Needs of Adolescent Idiopathic Scoliosis Patients and Their Parents in the UK: An Online Survey. Healthcare (Basel). 2019 Jun 20;7(2):78. doi: 10.3390/healthcare7020078.
PubMed 31226769Sykorova, K., Pavel, N., Mathew, A., Johnsen, M. B., Lystad, J. U., Bull, H. C., Gazerani, P., Kvammen, M. F., He, H.-G., Jacoby, J., & Pikkarainen, M. A. (under review). Understanding the needs and frustrations in adolescent idiopathic scoliosis: A qualitative interview study. Submitted to BMC Musculoskeletal Disorders.
Sykorova, K., Mathew, A., Pavel, N., Gazerani, P., Fløystad, M. K., Wlosek, N., Bong, W. K., Saidi, T., Johnsen, M. B., He, H.-G., & Pikkarainen, M. (2026). Co-designing a scoliosis self-management mobile app with adolescents and parents: A theory-informed qualitative study [Preprint]. JMIR Preprints. https://doi.org/10.2196/preprints.95698
Souza, F. M. D. L. C., Santos, W. N. D., Dantas, J. D. C., Sousa, H. R. A. D., Moreira, O. A. A., & Silva, R. A. R. D. (2022). Development of a mobile application for prenatal care and content validation. Acta Paulista de Enfermagem, 35, eAPE01861. https://doi.org/10.37689/acta-ape/2022AO01861
Rick R, Hoye RE, Thron RW, Kumar V. Marketplace Clinics Complementing Diabetes Care for Urban Residing American Indians. J Prim Care Community Health. 2017 Oct;8(4):198-205. doi: 10.1177/2150131917720556. Epub 2017 Jul 14.
PubMed 28707507Moshi MR, Tooher R, Merlin T. SUITABILITY OF CURRENT EVALUATION FRAMEWORKS FOR USE IN THE HEALTH TECHNOLOGY ASSESSMENT OF MOBILE MEDICAL APPLICATIONS: A SYSTEMATIC REVIEW. Int J Technol Assess Health Care. 2018 Jan;34(5):464-475. doi: 10.1017/S026646231800051X. Epub 2018 Sep 11.
PubMed 30201060Mekler, E. D., Brühlmann, F., Tuch, A. N., & Opwis, K. (2017). Towards understanding the effects of individual gamification elements on intrinsic motivation and performance. Computers in human behavior, 71, 525-534. https://doi.org/10.1016/j.chb.2015.08.048
Marrelli, A. F. (2008). Collecting data through focus groups. Performance improvement, 47(4), 39-45. https://doi.org/10.1002/pfi.201
Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590. https://doi.org/10.1080/10447318.2018.1455307
Lewis, J. R. (1992). Psychometric evaluation of the post-study system usability questionnaire: The PSSUQ. In Proceedings of the human factors society annual meeting (Vol. 36, No. 16, pp. 1259-1260). Sage CA: Los Angeles, CA: Sage Publications. https://doi.org/10.1177/154193129203601617