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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
Delta University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Kyphosis

Eligibility Criteria

13 Years - 16 Years (Child)FemaleDoes not accept healthy volunteers

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

    First Posted
    February 6, 2023
    Last Updated
    February 18, 2023
    Sponsor
    Delta University for Science and Technology
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    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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