NCT03856008

Brief Summary

The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable healthy

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

February 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

February 25, 2019

Last Update Submit

June 17, 2019

Conditions

Keywords

cervical spinal stabilisation exercisesmuscle cross sectional areamuscle t2 relaxation time

Outcome Measures

Primary Outcomes (2)

  • Cervical muscles cross sectional area

    Measurement of the cross-sectional area of the examined muscles by axial mri images. The circles of the muscles will be drawn by hand and examined with a computer program.

    Change from baseline time at the end of 8 week

  • Cervical muscle T2 relaxation time

    T2 relaxation time of circled muscles will be measured with milliseconds. T2 axial and t2 mapping images will be obtained with mri.

    change from baseline time at the end of 8 week

Secondary Outcomes (6)

  • Cervical muscle strength

    change from baseline score at the end of 8 week

  • New York posture rating chart

    change from baseline score at the end of 8 week

  • Tragus angle measurement

    change from baseline score at the end of 8 week

  • Cervical flexor and extensor endurance test

    change from baseline score at the end of 8 week

  • Cervical range of motion measurement

    change from baseline score at the end of 8 week

  • +1 more secondary outcomes

Study Arms (3)

Exercises focused on flexor muscles.

EXPERIMENTAL

Flexor cervical stabilization exercises will be applied.

Other: Exercises focused on flexor muscles

Exercises focused on extensor muscles.

EXPERIMENTAL

Extensor cervical stabilization exercises will be applied.

Other: Exercises focused on extensor muscles

Control.

NO INTERVENTION

No intervention will be applied.

Interventions

Exercises emphasis flexor muscles.

Exercises focused on flexor muscles.

Exercises emphasis extensor muscles.

Exercises focused on extensor muscles.

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being healthy
  • age between 18 to 30 years
  • agree to participate in the study

You may not qualify if:

  • to undergo any surgical procedure of the vertebral column
  • inflammatory disease
  • rheumatological disease
  • history of malignancy
  • congenital spinal cord anomaly
  • congenital and/or spinal deformities
  • radiculopathy
  • myelopathy
  • other neurological disorders
  • vestibular disorders and/or trauma history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Sıhhıye, 06430, Turkey (Türkiye)

Location

Study Officials

  • Erdi Kayabınar, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

February 25, 2019

Primary Completion

May 2, 2019

Study Completion

June 17, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations