NCT05732090

Brief Summary

Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. They will be assessed at baseline and after three successive 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

February 6, 2023

Last Update Submit

May 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cobb angle

    Cobb angle by x-ray

    Change from Cobb angle at 3 months

Secondary Outcomes (1)

  • pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)

    Change from pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) at 2 months

Study Arms (2)

Control group (A)

EXPERIMENTAL

The control group will receive a therapeutic exercise program (3 sessions per week for two months).

Other: therapeutic exercise program

study Group (B)

EXPERIMENTAL

study group will received the same intervention in control group in addition to diaphragmatic myofascial release (3 sessions/week/two months).

Other: therapeutic exercise programOther: diaphragmatic myofascial release

Interventions

therapeutic exercise program (3 sessions/week/two months).

Control group (A)study Group (B)

therapeutic exercise program in addition to diaphragmatic myofascial release (3 sessions/week/two months).

study Group (B)

Eligibility Criteria

Age12 Years - 15 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
  • Age ranged from 12 to 15 years old.
  • selected from preparatory and secondary schools.

You may not qualify if:

  • free from any associated deformities other than the thoracic kyphotic deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

Related Publications (1)

  • Elabd OM, Elsamahy SA, Abdelmutilibe SM, Mohammed AH, Ali F, Elabd AM. Effect of Adding Diaphragmatic Myofascial Release to Corrective Exercise on the Thoracic Curvature Angle and Pulmonary Function Testing in Hyperkyphotic Adolescent Girls: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Mar 1;104(3):203-209. doi: 10.1097/PHM.0000000000002622. Epub 2024 Sep 16.

MeSH Terms

Conditions

Scheuermann Disease

Condition Hierarchy (Ancestors)

Spinal OsteochondrosisOsteochondrosisBone DiseasesMusculoskeletal DiseasesKyphosisSpinal CurvaturesSpinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor at faculty of physical therapy

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 16, 2023

Study Start

February 25, 2022

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations