Adolescent Idiopathic ScoliosisNCT05969301
Memory and Scoliosis Spinal Exercises
An observational study of Adolescent Idiopathic Scoliosis, run by International Institute of Behavioral Medicines at 1 site in Italy.
Trial summary
This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Specific spinal exercises for idiopathic scoliosis
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 29 Feb 2024
- Phase
- Observational
- 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 11 to 19 years
- All sexes
- Child, Adult
Study population: Adolescent idiopathic scoliosis, which is a three-dimensional deformity of the spine and trunk occurring in healthy pubertal children.
Who may be able to join
- a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians
- ability to read and understand the Italian language
Who cannot join
- any diagnosable cause of scoliosis
- leg-length discrepancy of > 1 cm
- lower limb deformities interfering with spinal posture,
- cardiac and/or respiratory dysfunction
- systemic illness
- previous spinal surgery,
- cognitive impairment
- refusal to adhere to the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Rocca
Calosso, 14052
Barbara Rocca, +393333653393, info.ellis.bm@gmail.com
About this study
Official title: Role of the Memory in the Spinal Exercises for Adolescent Idiopathic Scoliosis
This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Relationships between young individuals' answers and health-related quality of life will be evaluated.
Read the detailed description
This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. Literature found out that a memory-experience difference exists between pleasant and unpleasant situations and young people are expected to capture memories more accurately when these, as voiced for instance by outcome measures of health-related quality of life, are at their worst- rather than at their best-perceived level.
In Literature there are not studies which investigate the relationships between the memory of spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of life.
The study consists of a short self-administered questionnaire which will be given to young persons to complete. In more details, the survey is made of four questions collecting information on time to learn an exercise, time to perform an exercise, difficulty to do the exercise, commitment to perform the exercise. Further, participants will have to complete a self-administered health-related quality of life questionnaire, and namely the Scoliosis Research Society-22 patients questionnaire.
Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and health-related quality of life questionnaire will be also evaluated.
This study's usefulness relies on understanding which spinal exercises impact more on memory in order to increase a young persons' positive routines and improve their performance with rehabilitative programs, with the ultimate goal of growing their adherence to and satisfaction with treatment.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Specific spinal exercises for idiopathic scoliosis
- Keywords
- Health-related quality of life, Adolescents, Memory, Scoliosis, Exercise
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific spinal exercises for idiopathic scoliosisOther
The spinal esercises mainly include: active self-correction, strengthening spinal deep muscles while maintaining self-correction, segmentary stretching involving the limbs and back muscles, and postural task-oriented exercises (e.g. walking, standing, sitting).
What is being measured
The primary outcome is the main question the study is designed to answer.
SRS-22 patient questionnaire
Scoliosis Research Society-22 patient questionnaire. The maximum score in each domain (pain, function, self-image, and mental health) is 5 and minimum score is 1, with higher scores representing greater individual's quality of life.
Measured: At the moment of the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969301
- Sponsor's protocol ID
- 2023-003
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.
PubMed 24682356Monticone M, Baiardi P, Calabro D, Calabro F, Foti C. Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1412-7. doi: 10.1097/BRS.0b013e3181e88981.
PubMed 21030889
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Memory in the Spinal Exercises for Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05969301
- Acronym / sponsor ID
- 2023-003
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Health-related quality of life, Adolescents, Memory, Scoliosis, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 1 Aug 2023 (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 is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Relationships between young individuals' answers and health-related quality of life will be evaluated.
Detailed description
This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. Literature found out that a memory-experience difference exists between pleasant and unpleasant situations and young people are expected to capture memories more accurately when these, as voiced for instance by outcome measures of health-related quality of life, are at their worst- rather than at their best-perceived level.
In Literature there are not studies which investigate the relationships between the memory of spinal exercises as for adolescents with idiopathic scoliosis and health-related quality of life.
The study consists of a short self-administered questionnaire which will be given to young persons to complete. In more details, the survey is made of four questions collecting information on time to learn an exercise, time to perform an exercise, difficulty to do the exercise, commitment to perform the exercise. Further, participants will have to complete a self-administered health-related quality of life questionnaire, and namely the Scoliosis Research Society-22 patients questionnaire.
Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample being investigated. Statistical correlations between adolescents' answers and health-related quality of life questionnaire will be also evaluated.
This study's usefulness relies on understanding which spinal exercises impact more on memory in order to increase a young persons' positive routines and improve their performance with rehabilitative programs, with the ultimate goal of growing their adherence to and satisfaction with treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescent idiopathic scoliosis, which is a three-dimensional deformity of the spine and trunk occurring in healthy pubertal children.
Key inclusion criteria (2 listed)
- a primary diagnosis of Adolescent Idiopathic Scoliosis determined by expert clinicians
- ability to read and understand the Italian language
Key exclusion criteria (8 listed)
- any diagnosable cause of scoliosis
- leg-length discrepancy of > 1 cm
- lower limb deformities interfering with spinal posture,
- cardiac and/or respiratory dysfunction
- systemic illness
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 |
|---|---|---|
| Specific spinal exercises for idiopathic scoliosisThe spinal esercises mainly include: active self-correction, strengthening spinal deep muscles while maintaining self-correction, segmentary stretching involving the limbs and back muscles, and postural task-oriented exercises (e.g. walking, standing, sitting). | Other | – |
Primary outcome
SRS-22 patient questionnaire
Time frame: At the moment of the assessment
Scoliosis Research Society-22 patient questionnaire. The maximum score in each domain (pain, function, self-image, and mental health) is 5 and minimum score is 1, with higher scores representing greater individual's quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 24682356Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Ferrante S. Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial. Eur Spine J. 2014 Jun;23(6):1204-14. doi: 10.1007/s00586-014-3241-y. Epub 2014 Feb 28.
- Results publication: PubMed 21030889Monticone M, Baiardi P, Calabro D, Calabro F, Foti C. Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 Nov 15;35(24):E1412-7. doi: 10.1097/BRS.0b013e3181e88981.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by International Institute of Behavioral Medicines at 1 site in Italy.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Rocca (+393333653393, info.ellis.bm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRS-22 patient questionnaire (time frame: At the moment of the assessment). 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 NCT05969301, which also lists 2 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 28 Sep 2023.