Adolescent Idiopathic ScoliosisNCT03514082
Oxygen Consumption in Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion angle (Cobb) includes brace and therapeutic exercises. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Rigid Thermoplastic Spinal Brace
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 15 Jan 2019
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subject who come to our outpatient clinic will be assessed for eligibility.
Who may be able to join
- Cobb angle between 20-45 degree,
- Prescribed a rigid spinal brace by doctor
Who cannot join
- Having leg length discrepancy more than 1 centimeter
- Having a lung disease
- Having another orthopedic or neurologic disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eastern Mediterranean University
Mersin, Famagusta, 99628
About this study
Official title: Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined like decreased torsional movements of spine, increased muscular work and energy expenditure in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions, balance and lower extremity loading symmetry in AIS subjects who are getting conservative treatment.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Rigid Thermoplastic Spinal Brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid Thermoplastic Spinal BraceDevice
Custom made rigid thermoplastic brace with 23 hours daily wearing time.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Idiopathic Scoliosis | Subjects with AIS who are beginning to the conservative treatment. Receives: Device: Rigid Thermoplastic Spinal Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Oxygen Consumption
Oxygen consumption will be assessed with a mobile metabolic analyzer during walking on treadmill with 4 km/h gait speed. Recordings will be taken for 2 minutes after first 2 minutes of walking.
Measured: Assessment will be done at the end of first month of conservative treatment.
Secondary outcomes (3)
Pulmonary Functions
Forced vital capacity (FVC), Forced expiratory volume in one second (FEV1), FEV1/FVC ratio, peak expiratory flow (PEF), forced expiratory flow at 25-75 % of the pulmonary volume (FEF 25-75%) will be assessed with spirometer.
Measured: Assessment will be done at the end of first month of conservative treatment.
Balance
Balance will be assessed with a special equipment that gives deviation that lower values mean better.
Measured: Assessment will be done at the end of first month of conservative treatment.
Lower extremity loading symmetry
Plantar loading symmetry will be assessed with a pedobarograph located in the middle of a six meters walking way. Loading symmetry will be calculated and compared as percentage of total pressure.
Measured: Assessment will be done at the end of first month of conservative treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start15 Apr 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin YURT, Eastern Mediterranean University
- Investigators
- Yasin Yurt, Asst. Prof., Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514082
- Sponsor's protocol ID
- ETK00-2016-0141
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03514082
- Acronym / sponsor ID
- ETK00-2016-0141
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 2 May 2018 (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.
Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined like decreased torsional movements of spine, increased muscular work and energy expenditure in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions, balance and lower extremity loading symmetry in AIS subjects who are getting conservative treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Idiopathic Scoliosis | – | Device: Rigid Thermoplastic Spinal BraceSubjects with AIS who are beginning to the conservative treatment. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subject who come to our outpatient clinic will be assessed for eligibility.
Key inclusion criteria (2 listed)
- Cobb angle between 20-45 degree,
- Prescribed a rigid spinal brace by doctor
Key exclusion criteria (3 listed)
- Having leg length discrepancy more than 1 centimeter
- Having a lung disease
- Having another orthopedic or neurologic disorder
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 |
|---|---|---|
| Rigid Thermoplastic Spinal BraceCustom made rigid thermoplastic brace with 23 hours daily wearing time. | Device | Adolescent Idiopathic Scoliosis |
Primary outcome
Gait Oxygen Consumption
Time frame: Assessment will be done at the end of first month of conservative treatment.
Oxygen consumption will be assessed with a mobile metabolic analyzer during walking on treadmill with 4 km/h gait speed. Recordings will be taken for 2 minutes after first 2 minutes of walking.
3 secondary outcomes
Pulmonary Functions
Time frame: Assessment will be done at the end of first month of conservative treatment.
Balance
Time frame: Assessment will be done at the end of first month of conservative treatment.
Lower extremity loading symmetry
Time frame: Assessment will be done at the end of first month of conservative treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- 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.
Yasin Yurt, Asst. Prof. principal investigator
Eastern Mediterranean University
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 Eastern Mediterranean 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 2 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: finished, as of the sponsor's last update on 31 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Oxygen Consumption (time frame: Assessment will be done at the end of first month of conservative treatment.). 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 31 Jan 2019.