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Effects of Vertebral Derotation on Pulmonary Functions

Primary Purpose

Adolescent Idiopathic Scoliosis, Scoliosis Idiopathic

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vertebral derotation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring lung functions, vertebral derotation, chest intervention

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy -CuRecruiting
  • faculty of PT - cuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intervention group

control

Arm 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).

Outcomes

Primary Outcome Measures

(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).

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05805995
Brief Title
Effects of Vertebral Derotation on Pulmonary Functions
Official Title
Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Scoliosis Idiopathic
Keywords
lung functions, vertebral derotation, chest intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).
Arm Title
control
Arm Type
Experimental
Arm Description
The Control group received only posterior correction with routine chest physiotherapy (group B).
Intervention Type
Procedure
Intervention Name(s)
vertebral derotation
Other Intervention Name(s)
INCENTIVE SPIROMETER
Intervention Description
Incentive spirometer (Mediciser): Used for breathing exercises. Cycle ergometer ( Mijnhardt , St. Paul, MN): Used for lower limb exercise.
Primary Outcome Measure Information:
Title
(FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing
Description
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).
Time Frame
Five months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KHALED T AHMED, Asso Prof
Phone
01115586016
Email
khaled.takey@must.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
abla H saleh, prof
Phone
01001521055
Email
Abla_hamed2000@yahoo.com
Facility Information:
Facility Name
Faculty of Physical Therapy -Cu
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed s ali, lecturer
Phone
01068443366
Email
dr.shawky_2011@cu.edu.eg
Facility Name
faculty of PT - cu
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NISREEN A EL AHASS, PROF
Phone
0237969108
Email
Zayedsameh40@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
At first study protocol and informed consent
IPD Sharing Time Frame
January 2023 - June 2023
IPD Sharing Access Criteria
consent
Citations:
PubMed Identifier
15995121
Citation
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.
Results Reference
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Effects of Vertebral Derotation on Pulmonary Functions

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