An interventional study of DinSkoliose smartphone application in Adolescence Idiopathic Scoliosis and AIS, sponsored by Oslo Metropolitan University. Not yet recruiting at 1 site in Norway. Open to participants aged 10 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Treatment
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.
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.
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.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adolescent patients with AIS.
The Inclusion criteria for participants in our study are those:
The Exclusion criteria for participants in our study are those who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: DinSkoliose smartphone application
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12 weeks (post-intervention)
Plan to share: 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.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Oslo Metropolitan University