Muscle PhysiologyNCT04567914
Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function
An observational study of Muscle Physiology and Adolescent Idiopathic Scoliosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aimed in this study: 1. To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals 2. To investigate the effect of measured thickness and symmetry on pulmonary function test. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Physiology, Adolescent Idiopathic Scoliosis
- What is being tested?
- Bilaterally abdominal muscle thickness with ultrasonography
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 1 Apr 2021
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: 10-18 years old patient with AIS diagnosis 10-18 years old healthy adolescent volunteer
Who may be able to join
- Cobb angle over 10 degrees in radiological evaluation
- Between the ages of 10-18 and diagnosed with AIS by a specialist physiatrist
Who cannot join
- History of previous spinal surgery
- Patients using brace
- Those with any diagnosis of scoliosis other than AIS
- Those with a history of neuromuscular disease
- Previous spinal surgery
- Patients with neurological deficits on examination
Show all 14Show fewer
- Patients with acute or chronic lung pathology
- Patients with abdominal surgery or injury
- Double curve or multiple curve
- Patients with concomitant chronic diseases
- The child's legal guardian does not allow it to take the tests
- The control group:
- 10-18 volunteer adolescents without any health problems,
- In clinical evaluation: Healthy adolescents (without any asymmetric findings on three-way inspection, Adam's forward bend test and scoliometer) were included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
Official title: Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function Test in Adolescent Idiopathic Scoliosis
We aimed in this study:
- To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals
- To investigate the effect of measured thickness and symmetry on pulmonary function test.
Read the detailed description
This cross-sectional,case-control clinical study included 40 patients diagnosed with AIS and 40 age and gender -matched healthy individuals. AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements and were performed of bilaterally abdominal muscle thickness in both groups. Spirometry evaluation was performed in both groups. Intragroup and intergroup data were compared.
- Conditions
- Muscle Physiology, Adolescent Idiopathic Scoliosis
- Being tested
- Bilaterally abdominal muscle thickness with ultrasonography
- Keywords
- Abdominal muscle, Cobb angle, Imbalance, Spirometry, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilaterally abdominal muscle thickness with ultrasonographyDiagnostic test
Also called Spirometry
AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups. Spirometry evaluation was performed in both groups
| Study group | Role | What they receive |
|---|---|---|
| Adolescent idiopathic scoliosis | Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness of AIS patients diagnosed by a specialist. Spirometry evaluation was performed by the investigator Receives: Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonography | |
| Adolescent healthy individuals | Healthy adolescents aged 10-18 were selected. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness. Spirometry evaluation was performed by the investigator. Receives: Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Muscle Thickness Symmetry
bilateral ultrasonographic millimetric measurement
Measured: during evaluation, an average of 45 minutes
Secondary outcomes (2)
Spirometry
Forced expiratory volume 1 (FEV1), Forced vital capacity (FVC), FEV1/FVC, Peak expiratory flow (PEF)
Measured: during evaluation, an average of 30 minutes
Cobb angle
Measurements were made on orthoroentgenogram, Grouped as Cobb angle <20 and Cobb angle ≥20
Measured: during evaluation, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start15 Apr 2019
- Primary completion16 Dec 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle PhysiologyStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Muhsin DORAN, MD, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitalKadriye Öneş, Assoc Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567914
- Sponsor's protocol ID
- IstPMRTRH-SCO1
- Status last verified
- Jan 2024
- First submitted
- 24 Sep 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
PubMed 17877281Newton PO, Faro FD, Gollogly S, Betz RR, Lenke LG, Lowe TG. Results of preoperative pulmonary function testing of adolescents with idiopathic scoliosis. A study of six hundred and thirty-one patients. J Bone Joint Surg Am. 2005 Sep;87(9):1937-46. doi: 10.2106/JBJS.D.02209.
PubMed 16140807Linek P. Body Mass Normalization for Lateral Abdominal Muscle Thickness Measurements in Adolescent Athletes. J Ultrasound Med. 2017 Sep;36(9):1851-1857. doi: 10.1002/jum.14218. Epub 2017 May 15.
PubMed 28503815Yang HS, Yoo JW, Lee BA, Choi CK, You JH. Inter-tester and intra-tester reliability of ultrasound imaging measurements of abdominal muscles in adolescents with and without idiopathic scoliosis: a case-controlled study. Biomed Mater Eng. 2014;24(1):453-8. doi: 10.3233/BME-130830.
PubMed 24211927Dreimann M, Hoffmann M, Kossow K, Hitzl W, Meier O, Koller H. Scoliosis and chest cage deformity measures predicting impairments in pulmonary function: a cross-sectional study of 492 patients with scoliosis to improve the early identification of patients at risk. Spine (Phila Pa 1976). 2014 Nov 15;39(24):2024-33. doi: 10.1097/BRS.0000000000000601.
PubMed 25202929
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function Test in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04567914
- Acronym / sponsor ID
- IstPMRTRH-SCO1
- Conditions
- Muscle Physiology, Adolescent Idiopathic Scoliosis
- Keywords
- Abdominal muscle, Cobb angle, Imbalance, Spirometry, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 29 Sep 2020 (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.
We aimed in this study:
- To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals
- To investigate the effect of measured thickness and symmetry on pulmonary function test.
Detailed description
This cross-sectional,case-control clinical study included 40 patients diagnosed with AIS and 40 age and gender -matched healthy individuals. AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements and were performed of bilaterally abdominal muscle thickness in both groups. Spirometry evaluation was performed in both groups. Intragroup and intergroup data were compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent idiopathic scoliosis | – | Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonographyUltrasonographic measurements were performed of bilaterally abdominal muscle thickness of AIS patients diagnosed by a specialist. Spirometry evaluation was performed by the investigator |
| Adolescent healthy individuals | – | Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonographyHealthy adolescents aged 10-18 were selected. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness. Spirometry evaluation was performed by the investigator. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 10-18 years old patient with AIS diagnosis 10-18 years old healthy adolescent volunteer
Key inclusion criteria (2 listed)
- Cobb angle over 10 degrees in radiological evaluation
- Between the ages of 10-18 and diagnosed with AIS by a specialist physiatrist
Key exclusion criteria (14 listed)
- History of previous spinal surgery
- Patients using brace
- Those with any diagnosis of scoliosis other than AIS
- Those with a history of neuromuscular disease
- Previous spinal surgery
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 |
|---|---|---|
| Bilaterally abdominal muscle thickness with ultrasonographyAlso: SpirometryAIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups. Spirometry evaluation was performed in both groups | Diagnostic test | Adolescent healthy individuals, Adolescent idiopathic scoliosis |
Primary outcome
Abdominal Muscle Thickness Symmetry
Time frame: during evaluation, an average of 45 minutes
bilateral ultrasonographic millimetric measurement
2 secondary outcomes
Spirometry
Time frame: during evaluation, an average of 30 minutes
Cobb angle
Time frame: during evaluation, an average of 30 minutes
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 23 Jan 2024.
- Background: PubMed 17877281Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
- Background: PubMed 16140807Newton PO, Faro FD, Gollogly S, Betz RR, Lenke LG, Lowe TG. Results of preoperative pulmonary function testing of adolescents with idiopathic scoliosis. A study of six hundred and thirty-one patients. J Bone Joint Surg Am. 2005 Sep;87(9):1937-46. doi: 10.2106/JBJS.D.02209.
- Results publication: PubMed 28503815Linek P. Body Mass Normalization for Lateral Abdominal Muscle Thickness Measurements in Adolescent Athletes. J Ultrasound Med. 2017 Sep;36(9):1851-1857. doi: 10.1002/jum.14218. Epub 2017 May 15.
- Results publication: PubMed 24211927Yang HS, Yoo JW, Lee BA, Choi CK, You JH. Inter-tester and intra-tester reliability of ultrasound imaging measurements of abdominal muscles in adolescents with and without idiopathic scoliosis: a case-controlled study. Biomed Mater Eng. 2014;24(1):453-8. doi: 10.3233/BME-130830.
- Results publication: PubMed 25202929Dreimann M, Hoffmann M, Kossow K, Hitzl W, Meier O, Koller H. Scoliosis and chest cage deformity measures predicting impairments in pulmonary function: a cross-sectional study of 492 patients with scoliosis to improve the early identification of patients at risk. Spine (Phila Pa 1976). 2014 Nov 15;39(24):2024-33. doi: 10.1097/BRS.0000000000000601.
- Individual participant dataSharing planned: No
Related trials for Muscle Physiology
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Muhsin DORAN, MD principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Kadriye Öneş, Assoc Prof study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Muscle Physiology and Adolescent Idiopathic Scoliosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 14 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 23 Jan 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 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?
Abdominal Muscle Thickness Symmetry (time frame: during evaluation, an average of 45 minutes). 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 NCT04567914, which also lists 5 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 23 Jan 2024.