Smartphone App for Adolescents With Idiopathic Scoliosis

NCT07686848 | Not Yet Recruiting

• 1 other identifier: 933077
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adolescence Idiopathic Scoliosis; AIS

Keywords

scoliosis; app; digital health; treatment adherence; self-determination theory; self-efficacy; social support; theory driven

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline to 12 weeks

Secondary Outcomes (4)

• User engagement measured by User Engagement Scale (UES)

  Week 6 and Week 12

• Change in perceived social support measured by Medical Outcomes Study Social Support Survey (MOS-SSS)

  Baseline to 12 weeks

• App usability and acceptability measured by Mobile App Rating Scale (MARS)

  Week 6 and Week 12

• Participant experiences and perceived impact assessed through semi-structured interviews

  At 12 weeks (post-intervention)

Study Arms (1)

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.

Device: DinSkoliose smartphone application

Interventions

DinSkoliose smartphone application DEVICE

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.

Intervention: DinSkoliose App

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator
• Ryggforeningen i Norge, Norway: collaborator

Study Sites (1)

OsloMet

Oslo, 0130, Norway

Location

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MeSH Terms

Conditions

Scoliosis; Alzheimer Disease; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, quasi-experimental study with a pretest-posttest design (no comparator group)

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): April 1, 2028
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

NO (1)