Effects of Vertebral Derotation on Pulmonary Functions

March 28, 2023 updated by: Khaled Takey Ahmed, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy -Cu
        • Contact:
      • Giza, Egypt
        • Recruiting
        • faculty of PT - cu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).
Procedure: vertebral derotation
  • Incentive spirometer (Mediciser): Used for breathing exercises.
  • Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.
Other Names:
  • INCENTIVE SPIROMETER
Experimental: control
The Control group received only posterior correction with routine chest physiotherapy (group B).
Procedure: vertebral derotation
  • Incentive spirometer (Mediciser): Used for breathing exercises.
  • Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.
Other Names:
  • INCENTIVE SPIROMETER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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).
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 15, 2023

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • veretebral derotation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At first study protocol and informed consent

IPD Sharing Time Frame

January 2023 - June 2023

IPD Sharing Access Criteria

consent

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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