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Pilates Mat Versus Cervical Stabilization Exercises on Balance in Young Adults With Forward Head Posture (FHP)

Primary Purpose

Musculoskeletal Diseases

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Pilates mat exercises

cervical stabilization exercises

conventional physiotherapy

About this trial

This is an interventional other trial for Musculoskeletal Diseases focused on measuring Balance, Craniovertebral angle

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects of both genders aged 18-25 years old with forward head posture will be included in this study.
Subjects have forward head posture if the craniovertebral angle ≤ 50.
Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months.
Normal body mass index (18- 24.9).

Exclusion Criteria:

Subjects with any spinal problems.
Temporo-mandibular disease.
Subjects with experience in Pilates and who will not sedentary were excluded from the study.
Previous surgery in the neck and shoulder regions
Current participation in a structured exercises program
Neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
Red flags suggesting of cancer, infection, vascular insufficiency.
Cervical radiculopathy or myelopathy

Sites / Locations

Faculty of Physical Therapy-Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Pilates mat exercises

cervical stabilization exercises

conventional physiotherapy

Arm Description

one hour Pilates exercises with 10 min warm up and 5-10 min cooling down

training of deep cervical flexor muscles with pressure biofeedback unit

10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program

Outcomes

Primary Outcome Measures

Dynamic balance

will be measured by Biodex balance system

Craniovertebral angle

will be measured by photogrammetric method

Secondary Outcome Measures

pain intensity

by visual analogue scale (VAS) 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain

cervical range of motion

by cervical range of motion device (CROM)

Function of daily life

by Arabic version of neck disability index

Full Information

NCT ID

NCT05068817

First Posted

September 16, 2021

Last Updated

July 24, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05068817

Brief Title

Pilates Mat Versus Cervical Stabilization Exercises on Balance in Young Adults With Forward Head Posture

Acronym

FHP

Official Title

Pilates Mat Versus Cervical Stabilization Exercises on Craniovertebral Angle, Pain, Function of Daily Life, Cervical Range of Motion, Dynamic Balance in Young Adults With Forward Head Posture: Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

January 1, 2022 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

see if there will be no statistical significant difference between the effects of Pilates mat versus cervical stabilization exercises on dynamic balance in young adults with forward head posture.

Detailed Description

In modernized time, extended use of mobile phone and computers has increased anterior weight bearing of cervical spine leading to a variety of musculoskeletal disorders related to the neck by changing the biomechanical stress of cervical spine. Additionally, forward head posture (FHP) alters the center of gravity (COG) of the body that lead to mechanical modifications related to postural control in the torso and every joint. The body attempts to adapt to these changes by altering its balance control mechanisms; these adaptations decrease balance ability while performing different activities and increase the risk of falling and musculoskeletal injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Diseases

Keywords

Balance, Craniovertebral angle

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pilates mat exercises

Arm Type

Experimental

Arm Description

one hour Pilates exercises with 10 min warm up and 5-10 min cooling down

Arm Title

cervical stabilization exercises

Arm Type

Experimental

Arm Description

training of deep cervical flexor muscles with pressure biofeedback unit

Arm Title

conventional physiotherapy

Arm Type

Active Comparator

Arm Description

10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program

Intervention Type

Other

Intervention Name(s)

Pilates mat exercises

Intervention Description

Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring 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 cranio-cervical junction). Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises.

Intervention Type

Other

Intervention Name(s)

cervical stabilization exercises

Intervention Description

training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.

Intervention Type

Other

Intervention Name(s)

conventional physiotherapy

Intervention Description

10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks

Primary Outcome Measure Information:

Title

Dynamic balance

Description

will be measured by Biodex balance system

Time Frame

up to twelve weeks

Title

Craniovertebral angle

Description

will be measured by photogrammetric method

Time Frame

up to twelve weeks

Secondary Outcome Measure Information:

Title

pain intensity

Description

by visual analogue scale (VAS) 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain

Time Frame

up to twelve weeks

Title

cervical range of motion

Description

by cervical range of motion device (CROM)

Time Frame

up to twelve weeks

Title

Function of daily life

Description

by Arabic version of neck disability index

Time Frame

up to twelve weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects of both genders aged 18-25 years old with forward head posture will be included in this study. Subjects have forward head posture if the craniovertebral angle ≤ 50. Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months. Normal body mass index (18- 24.9). Exclusion Criteria: Subjects with any spinal problems. Temporo-mandibular disease. Subjects with experience in Pilates and who will not sedentary were excluded from the study. Previous surgery in the neck and shoulder regions Current participation in a structured exercises program Neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests) Red flags suggesting of cancer, infection, vascular insufficiency. Cervical radiculopathy or myelopathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haytham M Elhafez, Professor

Organizational Affiliation

professor of physical therapy- cairo university

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Physical Therapy-Cairo University

City

Giza

ZIP/Postal Code

12511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

we will share the results of the trial 1-craniovertebral angle 2-dynamic balance 3-pain level of neck area 4-function of daily life 5-cervical range of motion

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

the criteria will be accessed by the publication of trials in international journal

Learn more about this trial

Pilates Mat Versus Cervical Stabilization Exercises on Balance in Young Adults With Forward Head Posture

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