Effects of Vertebral Derotation on Pulmonary Functions

NCT ID: NCT05805995

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Idiopathic Scoliosis Scoliosis Idiopathic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).

Group Type EXPERIMENTAL

vertebral derotation

Intervention Type PROCEDURE

* Incentive spirometer (Mediciser): Used for breathing exercises.
* Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.

control

The Control group received only posterior correction with routine chest physiotherapy (group B).

Group Type EXPERIMENTAL

vertebral derotation

Intervention Type PROCEDURE

* Incentive spirometer (Mediciser): Used for breathing exercises.
* Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vertebral derotation

* Incentive spirometer (Mediciser): Used for breathing exercises.
* Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

INCENTIVE SPIROMETER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Khaled Takey Ahmed

Asssociate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Physical Therapy -Cu

Giza, , Egypt

Site Status RECRUITING

faculty of PT - cu

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

KHALED T AHMED, Asso Prof

Role: CONTACT

01115586016

abla H saleh, prof

Role: CONTACT

01001521055

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ahmed s ali, lecturer

Role: primary

01068443366

NISREEN A EL AHASS, PROF

Role: primary

0237969108

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15995121 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

veretebral derotation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.