Adolescent Idiopathic ScoliosisNCT05805995
Effects of Vertebral Derotation on Pulmonary Functions
A study testing vertebral derotation in people with Adolescent Idiopathic Scoliosis and Scoliosis Idiopathic, run by Cairo University at 2 sites in Egypt.
Trial summary
This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Scoliosis Idiopathic
- What is being tested?
- vertebral derotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Jan 2023to 15 Jun 2023
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male patients suffering from adolescent idiopathic scoliosis.
- Participant age ranged from 12- 18 years old.
- All patients had the same medical care.
- Participants have received a good explanation of the treatment and measurement device.
- Treatment was conducted surgical intervention.
Who cannot join
- Instability of patient's medical condition.
- Presence of any diseases that could affect the study results.
- Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Physical Therapy -Cu
Giza
ahmed s ali, lecturer, 01068443366, dr.shawky_2011@cu.edu.eg
- Recruiting
faculty of PT - cu
Giza
NISREEN A EL AHASS, PROF, 0237969108, Zayedsameh40@yahoo.com
About this study
Official title: Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis
This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.
Read the detailed description
Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.
Patients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1.
- Being tested
- vertebral derotation
- Keywords
- lung functions, vertebral derotation, chest intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertebral derotationProcedure or surgery
Also called INCENTIVE SPIROMETER
- Incentive spirometer (Mediciser): Used for breathing exercises.
- Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A). Receives: Procedure: vertebral derotation |
| control | Experimental | The Control group received only posterior correction with routine chest physiotherapy (group B). Receives: Procedure: vertebral derotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing
Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start11 Jan 2023
- Primary completion30 May 2023 (estimated)
- Study completion15 Jun 2023 (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 Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A). The Control group received only posterior correction with routine chest physiotherapy (group B).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Takey Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805995
- Sponsor's protocol ID
- veretebral derotation
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At first study protocol and informed consent
Publications
Kim YJ, Lenke LG, Bridwell KH, Kim KL, Steger-May K. Pulmonary function in adolescent idiopathic scoliosis relative to the surgical procedure. J Bone Joint Surg Am. 2005 Jul;87(7):1534-41. doi: 10.2106/JBJS.C.00978.
PubMed 15995121
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis
- ClinicalTrials.gov ID
- NCT05805995
- Acronym / sponsor ID
- veretebral derotation
- Keywords
- lung functions, vertebral derotation, chest intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 10 Apr 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 study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.
Detailed description
Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.
Patients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A). The Control group received only posterior correction with routine chest physiotherapy (group B).
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: vertebral derotationThe exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A). |
| control | Experimental | Procedure: vertebral derotationThe Control group received only posterior correction with routine chest physiotherapy (group B). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male patients suffering from adolescent idiopathic scoliosis.
- Participant age ranged from 12- 18 years old.
- All patients had the same medical care.
- Participants have received a good explanation of the treatment and measurement device.
- Treatment was conducted surgical intervention.
Key exclusion criteria (3 listed)
- Instability of patient's medical condition.
- Presence of any diseases that could affect the study results.
- Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.
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 |
|---|---|---|
| vertebral derotationAlso: INCENTIVE SPIROMETER* Incentive spirometer (Mediciser): Used for breathing exercises. * Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise. | Procedure or surgery | control, intervention group |
Primary outcome
(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing
Time frame: Five months
Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 15995121Kim YJ, Lenke LG, Bridwell KH, Kim KL, Steger-May K. Pulmonary function in adolescent idiopathic scoliosis relative to the surgical procedure. J Bone Joint Surg Am. 2005 Jul;87(7):1534-41. doi: 10.2106/JBJS.C.00978.
- Individual participant dataSharing planned: Yes. At first study protocol and informed consent
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vertebral derotation in people with Adolescent Idiopathic Scoliosis and Scoliosis Idiopathic, run by Cairo University at 2 sites in Egypt.
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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 KHALED T AHMED, Asso Prof (01115586016, khaled.takey@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing (time frame: Five months). 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 NCT05805995, 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 10 Apr 2023.