Effect of Diaphragmatic Myofascial Release on Pulmonary Function in Kyphotic Adolescents
Primary Purpose
Adolescent Kyphosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic exercise program with pulmonary training
diaphragmatic myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Kyphosis
Eligibility Criteria
Inclusion Criteria: Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree. Age ranged from 13 to 16 years old. selected from preparatory and secondary schools. Exclusion Criteria: free from any associated deformities other than the thoracic kyphotic deformity.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group (A)
study Group (B)
Arm Description
control group will received therapeutic exercise program with pulmonary training by incentive mechanical respiratory training spirometer (3 sessions/week/two months).
study group will received the same intervention in control group in addition to diaphragmatic myofascial release (3 sessions/week/two months).
Outcomes
Primary Outcome Measures
Cobb angle
Cobb angle by x-ray
Secondary Outcome Measures
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Full Information
NCT ID
NCT05732090
First Posted
February 6, 2023
Last Updated
February 18, 2023
Sponsor
Delta University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05732090
Brief Title
Effect of Diaphragmatic Myofascial Release on Pulmonary Function in Kyphotic Adolescents
Official Title
Effect of Diaphragmatic Myofascial Release on Pulmonary Function in Kyphotic Adolescents: Randomized Control Trail
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 25, 2023 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology
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
Adolescents kyphotic girls will participated in this study. they will divided into two groups. Group A: control group will received therapeutic exercise program with pulmonary training by incentive mechanical respiratory training spirometer. Group B: study group will received the same intervention in group A in addition to diaphragmatic myofascial release. They will assessed at the baseline time and after successive two months of interventions for the following outcomes: Cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Detailed Description
Adolescents kyphotic girls with age ranged from 13-16 years old will participated in this study. they will divided into two groups. Group A: control group will received therapeutic exercise program with pulmonary training by incentive mechanical respiratory training spirometer. Group B: study group will received the same intervention in group A in addition to diaphragmatic myofascial release. both group will received intervention for successive two months. they will assessed at the baseline time and after successive two months of interventions for the following outcomes:
Primary outcome: Cobb angle by x-ray Secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Kyphosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group (A)
Arm Type
Experimental
Arm Description
control group will received therapeutic exercise program with pulmonary training by incentive mechanical respiratory training spirometer (3 sessions/week/two months).
Arm Title
study Group (B)
Arm Type
Experimental
Arm Description
study group will received the same intervention in control group in addition to diaphragmatic myofascial release (3 sessions/week/two months).
Intervention Type
Other
Intervention Name(s)
therapeutic exercise program with pulmonary training
Intervention Description
therapeutic exercise program with pulmonary training (3 sessions/week/two months).
Intervention Type
Other
Intervention Name(s)
diaphragmatic myofascial release
Intervention Description
therapeutic exercise program with pulmonary training in addition to diaphragmatic myofascial release (3 sessions/week/two months).
Primary Outcome Measure Information:
Title
Cobb angle
Description
Cobb angle by x-ray
Time Frame
Change from Cobb angle at 2 months
Secondary Outcome Measure Information:
Title
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)
Description
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Time Frame
Change from pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) at 2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
Age ranged from 13 to 16 years old.
selected from preparatory and secondary schools.
Exclusion Criteria:
free from any associated deformities other than the thoracic kyphotic deformity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Mohammed, PHD
Phone
01144495063
Email
amira_hussin77@yaho.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Diaphragmatic Myofascial Release on Pulmonary Function in Kyphotic Adolescents
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