Scoliosis Idiopathic AdolescentAR-AISNCT07067125
Augmented Reality-Assisted Physiotherapy for Adolescents With Idiopathic Scoliosis: A Qualitative Study
A study testing AR-Supported Scoliosis-Specific Physiotherapy in people with Scoliosis Idiopathic Adolescent and Scoliosis Idiopathic Adolescent Treatment, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore the effects of augmented reality (AR)-supported physiotherapy on body awareness, motivation, and exercise adherence in adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Scoliosis Idiopathic Adolescent Treatment
- What is being tested?
- AR-Supported Scoliosis-Specific Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 10 and 18 years
- Diagnosed with adolescent idiopathic scoliosis (AIS)
- Completed at least 4 weeks of AR-based physiotherapy
- Sufficient Turkish language proficiency to participate in interviews
- Provided written informed consent (adolescent and guardian)
Who cannot join
- Presence of neurological or cognitive conditions interfering with communication
- Withdrew before completing the intervention program
- Declined audio recording of interviews
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep
MERVE KARATEL, PhD, +905348293531, kmerve.karatel@hku.edu.tr
About this study
Official title: A Qualitative Evaluation of the Effects of Augmented Reality-Supported Training Methods on Body Awareness and Exercise Adherence in Adolescents With Idiopathic Scoliosis
This study aims to explore the effects of augmented reality (AR)-supported physiotherapy on body awareness, motivation, and exercise adherence in adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS). Using a qualitative phenomenological approach, the study will involve semi-structured interviews with adolescents who have completed at least four weeks of AR-based physiotherapeutic scoliosis-specific exercises. The goal is to understand participants' lived experiences with AR-enhanced rehabilitation and to inform the development of adolescent-centered, technology-integrated physiotherapy strategies in conservative scoliosis care.
Read the detailed description
This prospective qualitative study is designed to examine how adolescents with AIS experience AR supported physiotherapeutic scoliosis-specific exercises. A phenomenological design was selected to capture participants' lived experiences, perceptions of body awareness, and motivational responses to the intervention. The study will be conducted in a physiotherapy unit in Türkiye, with ethics approval obtained from the institutional review board. Eligible participants will include adolescents aged 10 to 18 years who are clinically diagnosed with AIS and have completed a minimum of four weeks of AR-based physiotherapy delivered by licensed physiotherapists. The AR intervention incorporates visual feedback, avatar-based motion monitoring, and gamified elements to support postural correction and therapeutic engagement. Data will be collected through face-to-face, semi-structured interviews using an interview guide informed by existing literature and expert consultation. Interviews will explore how participants perceive their postural awareness, exercise motivation, adherence challenges, and psychosocial adjustments within the AR-supported environment. All interviews will be audio-recorded and transcribed verbatim. Collected data will be analyzed using Braun and Clarke's thematic analysis framework, supported by NVivo software. Two independent researchers will code the transcripts to ensure analytical rigor and thematic validity. The study is expected to contribute to the refinement of conservative scoliosis rehabilitation practices by integrating adolescent perspectives and addressing the biopsychosocial dimensions of care enhanced through technology.
- Being tested
- AR-Supported Scoliosis-Specific Physiotherapy
- Keywords
- Adolescent idiopathic scoliosis, augmented reality, qualitative research, psychosocial adjustment, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-Supported Scoliosis-Specific PhysiotherapyBehavioural
Also called AR-Physio
This intervention consists of scoliosis-specific physiotherapy supported by AR technology. Participants will engage in postural correction exercises delivered by licensed physiotherapists using an AR system that provides real-time avatar feedback, movement guidance, and gamified motivation. The intervention aims to improve body awareness, adherence, and motivation among adolescents diagnosed with AIS. Each participant will complete at least four weeks of structured AR-supported sessions.
| Study group | Role | What they receive |
|---|---|---|
| AR-Supported Physiotherapy Group | Experimental | Adolescents in this arm will receive scoliosis-specific physiotherapy supported by AR for a minimum of four weeks. The intervention includes real-time avatar feedback, interactive postural training, and gamified components. Exercises are delivered by licensed physiotherapists using a standardized AR interface. This group is designed to evaluate participants' experiences of body awareness, motivation, and adherence in technology-integrated conservative scoliosis care. Receives: Behavioral: AR-Supported Scoliosis-Specific Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Awareness Following AR-Supported Physiotherapy
This outcome will assess adolescents' subjective body awareness, including their perception of postural alignment, movement control, and physical self-understanding, after completing AR-supported scoliosis-specific physiotherapy. Data will be collected through semi-structured interviews and analyzed thematically to evaluate perceived changes in awareness.
Measured: Within 1 week after completing the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jun 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis Idiopathic AdolescentStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilizes a single-group interventional design in which all participants will receive augmented reality-supported physiotherapeutic scoliosis-specific exercises for a minimum of four weeks. The intervention will be delivered by licensed physiotherapists using a standardized protocol that includes real-time visual feedback and interactive training components. No control or comparison group is included. This design was selected to qualitatively explore participants' individual experiences, perceptions of body awareness, motivational responses, and adherence behaviors during AR-based rehabilitation. Data will be collected through post-intervention interviews.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Merve Karatel, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067125
- Sponsor's protocol ID
- 2025/060
- Other IDs
- 323s271
- Acronym
- AR-AIS
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a qualitative study that involves in-depth interviews with adolescent participants diagnosed with idiopathic scoliosis. Due to the sensitive and identifiable nature of the data, individual participant data (IPD) will not be shared in order to protect confidentiality and adhere to ethical standards approved by the institutional review board. The collected data are not anonymized in a manner that would allow public sharing without risk of identification.
Publications
Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Evaluation of the Effects of Augmented Reality-Supported Training Methods on Body Awareness and Exercise Adherence in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07067125
- Acronym / sponsor ID
- AR-AIS / 2025/060
- Keywords
- Adolescent idiopathic scoliosis, augmented reality, qualitative research, psychosocial adjustment, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Jul 2025 (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.
This study aims to explore the effects of augmented reality (AR)-supported physiotherapy on body awareness, motivation, and exercise adherence in adolescents diagnosed with Adolescent Idiopathic Scoliosis (AIS). Using a qualitative phenomenological approach, the study will involve semi-structured interviews with adolescents who have completed at least four weeks of AR-based physiotherapeutic scoliosis-specific exercises. The goal is to understand participants' lived experiences with AR-enhanced rehabilitation and to inform the development of adolescent-centered, technology-integrated physiotherapy strategies in conservative scoliosis care.
Detailed description
This prospective qualitative study is designed to examine how adolescents with AIS experience AR supported physiotherapeutic scoliosis-specific exercises. A phenomenological design was selected to capture participants' lived experiences, perceptions of body awareness, and motivational responses to the intervention. The study will be conducted in a physiotherapy unit in Türkiye, with ethics approval obtained from the institutional review board. Eligible participants will include adolescents aged 10 to 18 years who are clinically diagnosed with AIS and have completed a minimum of four weeks of AR-based physiotherapy delivered by licensed physiotherapists. The AR intervention incorporates visual feedback, avatar-based motion monitoring, and gamified elements to support postural correction and therapeutic engagement. Data will be collected through face-to-face, semi-structured interviews using an interview guide informed by existing literature and expert consultation. Interviews will explore how participants perceive their postural awareness, exercise motivation, adherence challenges, and psychosocial adjustments within the AR-supported environment. All interviews will be audio-recorded and transcribed verbatim. Collected data will be analyzed using Braun and Clarke's thematic analysis framework, supported by NVivo software. Two independent researchers will code the transcripts to ensure analytical rigor and thematic validity. The study is expected to contribute to the refinement of conservative scoliosis rehabilitation practices by integrating adolescent perspectives and addressing the biopsychosocial dimensions of care enhanced through technology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a single-group interventional design in which all participants will receive augmented reality-supported physiotherapeutic scoliosis-specific exercises for a minimum of four weeks. The intervention will be delivered by licensed physiotherapists using a standardized protocol that includes real-time visual feedback and interactive training components. No control or comparison group is included. This design was selected to qualitatively explore participants' individual experiences, perceptions of body awareness, motivational responses, and adherence behaviors during AR-based rehabilitation. Data will be collected through post-intervention interviews.
| Arm | Type | Receives |
|---|---|---|
| AR-Supported Physiotherapy Group | Experimental | Behavioral: AR-Supported Scoliosis-Specific PhysiotherapyAdolescents in this arm will receive scoliosis-specific physiotherapy supported by AR for a minimum of four weeks. The intervention includes real-time avatar feedback, interactive postural training, and gamified components. Exercises are delivered by licensed physiotherapists using a standardized AR interface. This group is designed to evaluate participants' experiences of body awareness, motivation, and adherence in technology-integrated conservative scoliosis care. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 10 and 18 years
- Diagnosed with adolescent idiopathic scoliosis (AIS)
- Completed at least 4 weeks of AR-based physiotherapy
- Sufficient Turkish language proficiency to participate in interviews
- Provided written informed consent (adolescent and guardian)
Key exclusion criteria (3 listed)
- Presence of neurological or cognitive conditions interfering with communication
- Withdrew before completing the intervention program
- Declined audio recording of interviews
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 |
|---|---|---|
| AR-Supported Scoliosis-Specific PhysiotherapyAlso: AR-PhysioThis intervention consists of scoliosis-specific physiotherapy supported by AR technology. Participants will engage in postural correction exercises delivered by licensed physiotherapists using an AR system that provides real-time avatar feedback, movement guidance, and gamified motivation. The intervention aims to improve body awareness, adherence, and motivation among adolescents diagnosed with AIS. Each participant will complete at least four weeks of structured AR-supported sessions. | Behavioural | AR-Supported Physiotherapy Group |
Primary outcome
Change in Body Awareness Following AR-Supported Physiotherapy
Time frame: Within 1 week after completing the 4-week intervention
This outcome will assess adolescents' subjective body awareness, including their perception of postural alignment, movement control, and physical self-understanding, after completing AR-supported scoliosis-specific physiotherapy. Data will be collected through semi-structured interviews and analyzed thematically to evaluate perceived changes in awareness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Results publication: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a qualitative study that involves in-depth interviews with adolescent participants diagnosed with idiopathic scoliosis. Due to the sensitive and identifiable nature of the data, individual participant data (IPD) will not be shared in order to protect confidentiality and adhere to ethical standards approved by the institutional review board. The collected data are not anonymized in a manner that would allow public sharing without risk of identification.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR-Supported Scoliosis-Specific Physiotherapy in people with Scoliosis Idiopathic Adolescent and Scoliosis Idiopathic Adolescent Treatment, run by Hasan Kalyoncu 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ADNAN BATUHAN COŞKUN, PhD (+905323901464, adnanbatuhan.coskun@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Awareness Following AR-Supported Physiotherapy (time frame: Within 1 week after completing the 4-week intervention). 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 NCT07067125, which also lists 1 linked publication.
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 16 Jul 2025.