Adherence, TreatmentNCT05433545
Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire
An observational study of Adherence, Treatment and Spinal Deformity, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adherence, Treatment, Spinal Deformity
- What is being tested?
- Questionnaire
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2022to Dec 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with spinal deformity treated with Physiotherapy Scoliosis Specific Exercises
Who may be able to join
- aged between 10 and 18 years
- adolescent idiopathic scoliosis of 10 ° Cobb or more
- Scheuermann's kyphosis or idiopathic hyperkyphosis
- prescription of specific exercises
Who cannot join
- positive neurological evaluation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ISICO
Milan, Mi, 20141
Massimiliano Vanossi, PT, +3902 8416 1700, massimiliano.vanossi@isico.it
About this study
This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.
- Conditions
- Adherence, Treatment, Spinal Deformity
- Being tested
- Questionnaire
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Adolescents with spinal deformity will be asked to fill out a new questionnaire measuring the quality and quantity of adherence to specific physiotherapy exercises performed at home. Patients will be recruited at an outpatient service dedicated to the treatment of vertebral deformities during the monthly sessions with the physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Adherence to specific physiotherapy exercises | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Physiotherapy Scoliosis Specific Exercises
New questionnaire developped to assess quality and quantity of adherence to specific physiotherapy exercises performed at home patients with spinal deformity treated conservatively
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start22 Mar 2022
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimiliano Vanossi, PT, Principal investigator, Istituto Scientifico Italiano Colonna Vertebrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433545
- Sponsor's protocol ID
- AdePSSE
- Status last verified
- May 2024
- First submitted
- 21 Jun 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data will be shared on a repositiry
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire
- ClinicalTrials.gov ID
- NCT05433545
- Acronym / sponsor ID
- AdePSSE
- Conditions
- Adherence, Treatment, Spinal Deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jun 2022 (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 develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adherence to specific physiotherapy exercises | – | Other: Questionnaire |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with spinal deformity treated with Physiotherapy Scoliosis Specific Exercises
Key inclusion criteria (4 listed)
- aged between 10 and 18 years
- adolescent idiopathic scoliosis of 10 ° Cobb or more
- Scheuermann's kyphosis or idiopathic hyperkyphosis
- prescription of specific exercises
Key exclusion criteria (1 listed)
- positive neurological evaluation
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 |
|---|---|---|
| QuestionnaireAdolescents with spinal deformity will be asked to fill out a new questionnaire measuring the quality and quantity of adherence to specific physiotherapy exercises performed at home. Patients will be recruited at an outpatient service dedicated to the treatment of vertebral deformities during the monthly sessions with the physiotherapist | Other | Adherence to specific physiotherapy exercises |
Primary outcome
Adherence to Physiotherapy Scoliosis Specific Exercises
Time frame: through study completion, an average of 1 year
New questionnaire developped to assess quality and quantity of adherence to specific physiotherapy exercises performed at home patients with spinal deformity treated conservatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Yes. The raw data will be shared on a repositiry
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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.
Massimiliano Vanossi, PT principal investigator
Istituto Scientifico Italiano Colonna Vertebrale
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 Adherence, Treatment and Spinal Deformity, run by Istituto Scientifico Italiano Colonna Vertebrale 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 4 inclusion and 1 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 8 May 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Physiotherapy Scoliosis Specific Exercises (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.