NCT06220799

Brief Summary

-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? The participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales . Researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 4, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 14, 2024

Last Update Submit

January 14, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Craniovertebral angle (CVA)

    Taking photos from lateral view then craniovertebral angle measured by Kinovea software program.

    20 minutes

  • Cervical joint position error .

    Cervical joint position error via the CROM device,through the neutral head repositioning test (NHR) and the target head repositioning test (THR).

    40 minutes

  • Cervicogenic dizziness.

    Cervicogenic dizziness via score of Dizziness Handicap Inventory Questionnaire(DHI).

    10 minutes

  • The risk of falling.

    The risk of falling assessed by Berg Balance Scale(BBS) .

    20 minutes

  • The fear of falling.

    The fear of falling assessed by Fall Efficacy Scale-International(FES-I).

    10 minutes

Study Arms (2)

The Study group (GI)

The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ).

The Control group (GII)

The Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA = more than 49).

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will be enrolled in this study. Patients will be assigned into two groups (study and control groups) . The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA =more than 49°). Patients in group I were diagnosed as patients with chronic cervical radiculopathy with forward head posture (FHP) based on careful clinical evaluation by the neurologist . The patients will be recruited from the faculty of Physical Therapy, Cairo University, and private clinic in cairo .

You may qualify if:

  • The Patients will include if they have the following:
  • Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will participate in the study (twenty five with forward head posture (FHP) , and twenty five without forward head posture (FHP) ).
  • The duration of the disease (cervical radiculopathy)is more than 6 months.
  • The age ranged from 35 to 50 years old.
  • Mild to moderate neck pain on visual analogue scale .
  • Pain and dizziness lasting for 3-6 months.
  • subjective dizziness experienced in conjunction with cervical pain, movement, stiffness, or particular postures.

You may not qualify if:

  • The Patients will exclude if they exhibit any of the following:
  • Cervical myelopathy.
  • Cervical myelo-radiculopathy.
  • Acute cervical radiculopathy.
  • Diabetic neuropathy.
  • Previous cervical surgery.
  • Cervical trauma.
  • Deformities in the cervical spine .
  • Rheumatoid arthritis.
  • Any tumours and infection involving the cervical spine .
  • Patients with a history of neuromuscular disorders.
  • precise diagnosis of either central dizziness (due to cerebrovascular disorders related to the vertebrobasilar circulation, migraine, multiple sclerosis, tumours of the posterior fossa, neurodegenerative disorders, some drugs, and psychiatric disorders) or peripheral dizziness( due to a problem in the part of the inner ear that controls balance. These areas are called the vestibular labyrinth, or semicircular canals. The problem may also involve the vestibular nerve. This is the nerve between the inner ear and the brain stem).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Labs at Cairo University

Dokki, Giza Governorate, 12612, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Sara Aboud, Teaching Assistant

CONTACT

Ashraf Darwesh, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant of physical therapy for neuromuscular disorders and its surgeries

Study Record Dates

First Submitted

January 14, 2024

First Posted

January 24, 2024

Study Start

September 4, 2023

Primary Completion

January 29, 2024

Study Completion

January 29, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations