NCT05707130

Brief Summary

To determine the effects of gaze stabilization exercises on dizziness, balance and quality of life in patients with cervical spondylosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 23, 2023

Last Update Submit

March 31, 2023

Conditions

Keywords

DizzinessBalance; DistortedCervical Spondylosis

Outcome Measures

Primary Outcomes (3)

  • Romberg Test

    The Romberg test is a test that measures your sense of balance.

    9 months

  • Dizziness Handicap Inventory

    The DHI contains 25 items, and a total score (0-100 points) is obtained by summing ordinal scale responses, higher scores indicating more severe handicap. The scale was developed to capture various sub-domains of self- perceived handicap and comprises 7 physical, 9 functional, and 9 emotional questions. Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness.

    9 months

  • Vestibular Disorders Activities of Daily Living Scale

    The scale evaluates the effects of vertigo and balance disorders on independence in everyday activities of daily living. The tool is designed to be useful for evaluating functional limitation and perceived handicap and disability before and after therapeutic intervention. The scale evaluates the effects of vertigo and balance disorders on independence in everyday activities of daily living. The scale 28- item self-report questionnaire that is broken down into 3 subscales: 1. Functional- evaluates the individual's perception of basic self-maintenance tasks 2. Ambulatory-evaluates perception of mobility related tasks 3. Instrumental-evaluates self-perception in higher-level, more socially complex tasks

    9 months

Study Arms (2)

gaze stabilization exercises group

EXPERIMENTAL

Experimental group will receive Vestibulo ocular reflex VOR / gaze stabilization exercise, Static neck exercise, and Habituation exercise. Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.

Other: gaze stabilization exercises

control group

ACTIVE COMPARATOR

Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.

Other: neck isometrics

Interventions

patients will perform gaze stabilization exercise, Static neck exercise, and Habituation exercise. Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.

gaze stabilization exercises group

Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.

control group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pre diagnosed from orthopedic doctor with cervical spondylosis
  • Complaining of cervicogenic dizziness confirmed with positive results to the tests namely Romberg's test, dizziness handicap inventory

You may not qualify if:

  • Patients with cervical radiculopathy
  • Any drug allergy and neurological deficits were excluded from the study.
  • Dizziness due to ear infection and due to BPPV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (4)

  • Sun Y, Muheremu A, Tian W. Atypical symptoms in patients with cervical spondylosis: Comparison of the treatment effect of different surgical approaches. Medicine (Baltimore). 2018 May;97(20):e10731. doi: 10.1097/MD.0000000000010731.

    PMID: 29768345BACKGROUND
  • Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.

    PMID: 31615495BACKGROUND
  • Meng Z, Yu J, Luo C, Liu X, Jiang W, Yu L, Huang R. Anterior Cervical Spondylosis Surgical Interventions are Associated with Improved Lordosis and Neurological Outcomes at Latest Follow up: A Meta-analysis. Sci Rep. 2017 Jun 30;7(1):4407. doi: 10.1038/s41598-017-04311-6.

    PMID: 28667278BACKGROUND
  • Lv Y, Tian W, Chen D, Liu Y, Wang L, Duan F. The prevalence and associated factors of symptomatic cervical Spondylosis in Chinese adults: a community-based cross-sectional study. BMC Musculoskelet Disord. 2018 Sep 11;19(1):325. doi: 10.1186/s12891-018-2234-0.

    PMID: 30205836BACKGROUND

MeSH Terms

Conditions

DizzinessSpondylosis

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Zeest Hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be allocated to intervention groups by randomization. The patients in group A will be given gaze stabilization exercises and habituation exercises along with neck isometrics for 4 weeks. The patients in group B will be given neck isometrics for treatment of cervical spondylosis for 4 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 31, 2023

Study Start

January 1, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations