Effects of Stabilization Exercises and Posture Training on Breast Feeding Females Suffering From Scapular Dyskinesia

December 26, 2023 updated by: Riphah International University

Comparative Effects Of Stabilization Exercises And Posture Training On Pain Function And Range Of Motion In Breast Feeding Females Suffering From Scapular Dyskinesia

A randomized clinical trial study will be conducted through a non-probability convenience sampling technique. Study will be conducted at Jinnah Hospital, Lahore. Sample size will be collected through open epi tool. The total sample size of 52 is calculated. Two treatment groups will be taken for conducting the research. Group A with twenty-six (26) patients will be treated with stabilization exercises and Group B with twenty-six (26) patients whom will be treated with posture training. Difference between pre-treatment and post-treatment readings will be calculated using Paired sample t-test for parametric data. For nonparametric data Wilcoxon signed rank test will be used. This is a non-parametric test that compares paired groups. Generalized physiotherapy rehabilitation protocol will be implemented in Group A for scapular stabilization by demonstrating scapular retraction (Shoulder Blade Squeezes), External Rotation, Shoulder Diagonals, Horizontal Rows, Shoulder Extension, Angel Wings, Active: Push with a plus, Physio ball Scapular Exercises, Platform Walks. In Group B, postural training different nursing positions will be guided as crossover hold, laid-back position, on the pillow position, cradle, football hold, side-lying position. The intervention will be provided in twelve sessions over a 4-week intervention period (three sessions per week) each session of 30 to 50 minutes accompanied by an individual daily at-home exercise program. The participants were advised not to use other forms of treatment during the trial (pharmacologic or non-pharmacologic treatment). NPRS will be used to measure the pain intensity and functional limitation will be assessed using the UEFI, goniometer to check the range limitation. Total study duration will be ten months after the approval of synopsis. Data will be analysed by using SPSS 26.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scapular dyskinesis is a change or deviation in the normal resting or active position of the scapula during shoulder movement due to the repetitive use of the shoulder, most people's scapula moves abnormally. Scapular winging is a clinical observation in which any part of the scapular departs excessively from the thorax soon after movement begins causing hinderance in performing movements like Elevation/depression, Protraction/retraction, Internal/external rotation, Superior/inferior rotation, Anterior/posterior tilt. Scapular dyskinesia can be caused by one of three factors, Shoulder-related, Neck-related, Posture-related.

The significance of this study is to lessen the musculoskeletal disorders causing scapular dyskinesia through provision of the stabilization, stretching exercises and posture training, improving function and range of motion in breast feeding females.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Jinnah Hospital, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Positive Scapular Dyskinesis Test
  • Age 25-40 Years
  • Breast feeding females from last 6 months
  • Primigravida females

Exclusion Criteria:

  • Cesarean section females
  • Neck or shoulder pain due to any other comorbidity e.g. Previous history of trauma or fracture
  • Any spinal deformity like scoliosis or kyphosis
  • Disc prolapse facet joint stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stabilization Exercises
Twenty-six (26) patients will be treated with stabilization exercises in breast feeding females suffering from scapular dyskinesia.
Other: Stabilization Exercises
It consists of 26 patients who will receive stabilization exercises which will be divided in three components in lying posture, sitting, standing, rolling and kneeling positions to treat posterior, inferior muscles of scapula for 35-45 min for 3 days a week for 4 weeks.
Experimental: Posture Training
Twenty-six (26) patients will be treated with posture training of breast-feeding females suffering from scapular dyskinesia.
Other: Posture Training
It consists of 26 patients who will receive postural training and breast-feeding patterns for the mother and child for 35-45 min in 3 days a week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
RANGE OF MOTION
Time Frame: 4th Week
A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.
4th Week
Numeric Pain Rating scale
Time Frame: 4th week
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a one dimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. Validity 0.86 to 0.95
4th week
UPPER EXTREMITY FUNCTIONAL INDEX
Time Frame: 4th week
The Upper Extremity Functional Index is a patient reported outcome measure used to assess the functional impairment in individuals with musculoskeletal upper limb dysfunction.
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adeela Arif, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ashley Nudrat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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