Effects of Vertebral Derotation on Pulmonary Functions

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805995
• Other study ID #: veretebral derotation
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: KHALED T AHMED, Asso Prof
• Phone: 01115586016
• Email: khaled.takey[@]must.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis
• Scoliosis Idiopathic

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy -Cu	Giza
Egypt	faculty of PT - cu	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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).	Five months