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Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients

Primary Purpose

Dizziness, Balance; Distorted, Cervical Spondylosis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
gaze stabilization exercises
neck isometrics
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring Dizziness, Balance; Distorted, Cervical Spondylosis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gaze stabilization exercises group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Romberg Test
The Romberg test is a test that measures your sense of balance.
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.
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: Functional- evaluates the individual's perception of basic self-maintenance tasks Ambulatory-evaluates perception of mobility related tasks Instrumental-evaluates self-perception in higher-level, more socially complex tasks

Secondary Outcome Measures

Full Information

First Posted
January 23, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05707130
Brief Title
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients
Official Title
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Patients With Cervical Spondylosis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effects of gaze stabilization exercises on dizziness, balance and quality of life in patients with cervical spondylosis.
Detailed Description
A randomized controlled trial will be performed in which total 32 patients with cervical spondylosis will be included. The data will be collected from Riphah rehabilitation centre Lahore and Ittefaq hospital Lahore. The duration of study will be ten months. Dizziness handicap inventory, Romberg test and Vestibular Disorders Activities of Daily Living Scale will be used as data collection tools. Data collection will be started after taking informed consent from all patients. 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. After data collection, analysis of pre and post values will be done by using SPSS 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Balance; Distorted, Cervical Spondylosis
Keywords
Dizziness, Balance; Distorted, Cervical Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaze stabilization exercises group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
Intervention Type
Other
Intervention Name(s)
gaze stabilization exercises
Intervention Description
patients will perform gaze stabilization exercise, Static neck exercise, and Habituation exercise. Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.
Intervention Type
Other
Intervention Name(s)
neck isometrics
Intervention Description
Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
Primary Outcome Measure Information:
Title
Romberg Test
Description
The Romberg test is a test that measures your sense of balance.
Time Frame
9 months
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
9 months
Title
Vestibular Disorders Activities of Daily Living Scale
Description
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: Functional- evaluates the individual's perception of basic self-maintenance tasks Ambulatory-evaluates perception of mobility related tasks Instrumental-evaluates self-perception in higher-level, more socially complex tasks
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with cervical radiculopathy Any drug allergy and neurological deficits were excluded from the study. Dizziness due to ear infection and due to BPPV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeest Hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29768345
Citation
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.
Results Reference
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PubMed Identifier
31615495
Citation
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.
Results Reference
background
PubMed Identifier
28667278
Citation
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.
Results Reference
background
PubMed Identifier
30205836
Citation
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.
Results Reference
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Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients

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