NCT05068817

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

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

September 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

September 16, 2021

Last Update Submit

July 24, 2022

Conditions

Keywords

BalanceCraniovertebral angle

Outcome Measures

Primary Outcomes (2)

  • Dynamic balance

    will be measured by Biodex balance system

    up to twelve weeks

  • Craniovertebral angle

    will be measured by photogrammetric method

    up to twelve weeks

Secondary Outcomes (3)

  • pain intensity

    up to twelve weeks

  • cervical range of motion

    up to twelve weeks

  • Function of daily life

    up to twelve weeks

Study Arms (3)

Pilates mat exercises

EXPERIMENTAL

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

Other: Pilates mat exercisesOther: conventional physiotherapy

cervical stabilization exercises

EXPERIMENTAL

training of deep cervical flexor muscles with pressure biofeedback unit

Other: cervical stabilization exercisesOther: conventional physiotherapy

conventional physiotherapy

ACTIVE COMPARATOR

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

Other: conventional physiotherapy

Interventions

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.

Pilates mat exercises

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

cervical stabilization exercises

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

Pilates mat exercisescervical stabilization exercisesconventional physiotherapy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy-Cairo University

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Haytham M Elhafez, Professor

    professor of physical therapy- cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of physical therapy

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 6, 2021

Study Start

November 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
one year
Access Criteria
the criteria will be accessed by the publication of trials in international journal

Locations