NCT04716348

Brief Summary

Forward head posture is one of the most common postural deviation seen among visually impaired children and, it is characterized by hyperextension of upper cervical and flexion of lower cervical spine. These changes lead to muscle imbalance and resulting in weakness of the deep cervical flexors, shortening of the opposing cervical extensors and reduction in cervical range of motion. Muscle energy technique is a manual therapy technique using in the treatment of shortened muscles, muscle weakness, restricted joints range of motion. so this study aimed to investigate the efficacy of muscle energy technique on forward head posture and cervical mobility in visually impaired children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

January 11, 2021

Last Update Submit

May 9, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in craniovertebral angle

    analysis of craniovertebral angle form lateral view performed by AUTOCAD program

    baseline pre intervention and immediately after the intervention

  • change of cervical range of motion

    measurement of cervical range of motion including cervical flexion, cervical extension, cervical side bending, and cervical rotation. these measurement will be applied by CROM device

    baseline pre intervention and immediately after the intervention

Study Arms (2)

group A

EXPERIMENTAL

suboccipital muscle energy technique

Procedure: muscle energy technique

group B

SHAM COMPARATOR

sham muscle energy technique

Procedure: muscle energy technique

Interventions

muscle energy technique for suboccipital muscles

group Agroup B

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Visual acuity will be 6/24, 6/36 and 6/60 after correction.
  • Wearing glasses more than one year.
  • Craniovertebral angle \< 50°.
  • Functional hearing.

You may not qualify if:

  • Injury of cervical region (e.g: atlantoaxial instability).
  • Cervical spine deformities or/disorders.
  • History of previous cervical spine surgery.
  • Rheumatic and congenital heart disease.
  • Regular participation in any sport activities.
  • Intellectual or/mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noha Elserty

Cairo, Egypt

RECRUITING

Study Officials

  • Noha S Elserty, PhD

    Lecturer of physical therapy- Egyptian Chinese University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha S Elserty, PhD

CONTACT

Eman W Mahmoud, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 20, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

supporting information that will be shared after publication of the study

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after publishing the study

Locations