NCT06271850

Brief Summary

Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

February 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

April 23, 2025

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 15, 2024

Last Update Submit

April 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Measurement of craniovertebral angle (CVA)

    It will be measured before and after treatment program by using posture screen analysis mobile application. This method has many advantages, as it is relatively fast, the image and values obtained are easily preserved, and it is more precise and reliable than visual evaluation alone The CVA is the best indicator of FHP. To determine this angle, two references are defined: One line that runs from the swallow of the ear to seventh cervical vertebra (C7) and another horizontal line parallel to the ground that passes only through the spinous apophysis of C7. An angle of less than 50°-53° may indicate FHP. Thereby, the smaller the CVA, the greater the disability

    up to 8 weeks

  • Assessment of neck pain intensity

    It will be evaluated before and after treatment program by using VAS, which is a linear scale that measures the magnitude of pain severity. It encompasses a horizontal line scaled as a spectrum from mild pain beginning from the left to increasing severity to the right end of the horizontal line. The line is 10 cm in length, with each side of the line ending in extremes either no pain or intense pain. In terms of utilization, each participant will mark her pain on the line of the spectrum of the scale

    up to 8 weeks

  • Measurement of cervical range of motion

    It will be measured before and after treatment program by goniometer. The movements that will measured by the goniometer include flexion and extension, right and left lateral flexion, and right and left rotation. The goniometer will be placed on the participant's head. During all the measurements, the participant will be seated, with her back straight, and looking ahead; her feet will be supported on the floor. The participant will remain in the same sitting position from the moment the recording procedure will start. The measurement will be performed from "the neutral" position to the final range of motion in a given plane. The participant will perform a practice trial. During each trial, the movement will be executed to reflect the participant's maximum capabilities. When the maximum movement will be performed in one direction, the final position will be identified and recorded

    up to 8 weeks

Secondary Outcomes (5)

  • Evaluation of disability due to neck pain

    up to 8 weeks

  • Assessment of neck muscle fatigue

    up to 8 weeks

  • Assessment of breastfeeding self-efficacy

    up to 8 weeks

  • Measurement of weight and height of baby

    up to 8 weeks

  • Assessment of Health-Related Quality of Life

    up to 8 weeks

Study Arms (2)

Ergonomic breastfeeding training (control group)

ACTIVE COMPARATOR

They will receive ergonomics breastfeeding training only.

Other: Ergonomics breastfeeding training

Pilates exercises and ergonomic breastfeeding training (study group)

EXPERIMENTAL

They will receive Pilates exercises, in addition to ergonomics breastfeeding training.

Other: Ergonomics breastfeeding trainingOther: Pilates exercises

Interventions

The ergonomics training includes the most ergonomically appropriate methods to breastfeed and ergonomic guidelines, including how to cuddle and breastfeed the baby correctly.

Ergonomic breastfeeding training (control group)Pilates exercises and ergonomic breastfeeding training (study group)

Pilates exercises, 3 times per week, for 8 weeks, in the form of neck extensor stretching, neck extensor and rotation stretching, pectoral muscle stretching, strengthening of deep neck flexors and scapular retractor, and core strengthening exercises ( pelvic bridging, plank, cat and camel, curl up, single leg abdominal press and double leg abdominal press).

Pilates exercises and ergonomic breastfeeding training (study group)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women are breastfeeding and will have FHP.
  • They are between six to twelve months post-delivery.
  • They should have a single, healthy, and full-term baby without complications.
  • Their body mass index (BMI) will not exceed 30 Kg/m2.
  • Their parity will range from 2 to 3 children.
  • They are housewife.

You may not qualify if:

  • Cancer of the breast or the surrounding area, any previous breast or chest surgery, breast infection, retracted, cracked, inflamed or inverted nipples.
  • Any cardiorespiratory disease, anemia, or diabetes mellitus.
  • Recent fracture or surgery of the cervical spine or shoulder.
  • History of physical and mental diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Onsy Ewass

Port Said, Egypt

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Khadega S Abd El Aziz, PHD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

February 20, 2024

Primary Completion

December 20, 2024

Study Completion

January 20, 2025

Last Updated

April 23, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations