NCT05805995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

April 10, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 28, 2023

Last Update Submit

March 28, 2023

Conditions

Adolescent Idiopathic ScoliosisScoliosis Idiopathic

Keywords

lung functions, vertebral derotation, chest intervention

Outcome Measures

Primary Outcomes (1)

  • (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

Study Arms (2)

intervention group

EXPERIMENTAL

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

Procedure: vertebral derotation

control

EXPERIMENTAL

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

Procedure: vertebral derotation

Interventions

vertebral derotationPROCEDURE

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

Also known as: INCENTIVE SPIROMETER
controlintervention group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physical Therapy -Cu

Giza, Egypt

RECRUITING

faculty of PT - cu

Giza, Egypt

RECRUITING

Related 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.

    PMID: 15995121BACKGROUND

Central Study Contacts

KHALED T AHMED, Asso Prof

CONTACT

01115586016khaled.takey@must.edu.eg

abla H saleh, prof

CONTACT

01001521055Abla_hamed2000@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate Professor

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

January 11, 2023

Primary Completion

May 30, 2023

Study Completion

June 15, 2023

Last Updated

April 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

At first study protocol and informed consent

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
January 2023 - June 2023
Access Criteria
consent

Locations

EG(2)