Effect of Pilates on Balance and Spinal Curvature In Upper Crossed Syndrome (UCS)

February 15, 2023 updated by: Mariam omran Grase, Cairo University
The study will be conducted to investigate the effect of Pilates exercise on spinal curvature and balance in patients with the upper cross syndrome. .

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

Upper crossed syndrome (UCS) is the most common postural dysfunction in the musculature of the shoulder girdle /cervicothoracic region, which creates joint dysfunction, particularly at the atlanto-occipital joint, cervicothoracic joint C4-C5 segment, glenohumeral joint and T4-T5 segment. Pilates is designed as a program that will work with other exercise programs to strengthen, rebalance and realign the body. Pilates trains individuals to identify their own musculoskeletal strengths and weaknesses and equips them with the knowledge to correct and rebalance their entire body mechanics (Worth,2004) thus, the focus is also placed on improving personal body awareness which further decreases the risks of strain or injury that can occur with imbalances. forty patients with UCS will be allocated randomly into two groups; one experimental group will receive pilates exercise and postural correction twice a week for four weeks, and the control group will receive postural correction exercise along twice a week for four weeks

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.
40

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

  • Egypt
      • Giza, Egypt
        • Faculty of physical therapy Cairo

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

17 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient's age ranged from 17 to 22 years
  • Body mass index between 20-25 kg/m2
  • The participants are diagnosed with upper cross syndrome
  • Patients with normal cognitive aspects willing and able to participate in a program safely

Exclusion Criteria:

  • The participants have experienced any recent trauma (within 3 months of the initial consultation)
  • The participant's primary complaint is that of headaches or facial pain.
  • Contra-indications to pilates are found pregnancy, hypertension, osteoporosis, and spinal tumors.
  • Participants have any sort of structural abnormality in upper and middle back e.g., Scoliosis, or had a positive Adams test.
  • Participants who are taking anti-inflammatory or muscle relaxant medication had to have a three-day "wash out" period before participating in the study

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: Double

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: Pilates exercise
pilates exercise will be received twice a week for four weeks
Other: Pilates exercises
Each Pilates session will last for one hour. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centering which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the craniocervical junction). A pilates exercise program will consist of 11 levels of treatment program.
Other: postural correction exercise
the patients will receive postural correction exercises, stretches, and exercises to the pectoralis major, elevator scapulae, upper trapezius, serratus anterior, rhomboids, and deep neck flexors. The stretches included sitting chair stretches, Brugger's, wall angels, and doorway stretches. The exercises included push-up-plus, head-neck-retraction, and Kibler squeeze
Active Comparator: postural correction exercise
postural correction exercises will be received twice a week for four weeks
Other: postural correction exercise
the patients will receive postural correction exercises, stretches, and exercises to the pectoralis major, elevator scapulae, upper trapezius, serratus anterior, rhomboids, and deep neck flexors. The stretches included sitting chair stretches, Brugger's, wall angels, and doorway stretches. The exercises included push-up-plus, head-neck-retraction, and Kibler squeeze

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
spinal curvature
Time Frame: up to four weeks
spinal mouse will be used to assess thoracic spine curvature. Total angle of the thoracic spine is 41-44 degree.
up to four weeks
balance
Time Frame: up to four weeks
balance will be measured by Biodex balance system
up to four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
craniovertebral angle
Time Frame: up to four weeks
craniovertebral angle will be measured by photogrammetric method
up to four weeks
shoulder posture
Time Frame: up to four weeks
The shoulder's rounded position will be measured by tap measurement. the patients will be in supine and the therapist measure the distance from their shoulder to the plinth using tape measurements.
up to four weeks
pain intensity
Time Frame: up to four weeks
pain will be measured by visual analogue scale
up to four weeks
neck function
Time Frame: up to four weeks
neck function will be measured by Arabic neck disability index.. It consisting of 10 items with six choices. There is no disability for scores from 0 to 4; 5-14 is mild; 15-24 is moderate; 25-34 is severe, and finally more than 34 is a complete disability.
up to four weeks

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.
Cairo University

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.
October 25, 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.
December 1, 2022

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.
December 1, 2022

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).
October 19, 2022

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.
October 19, 2022

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.
October 24, 2022

Study Record Updates

Last Update Posted (Estimate)

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.
February 16, 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.
February 15, 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.
February 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.
  • P.T/012/003992

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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