- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707130
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Patients With Cervical Spondylosis.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Fedral
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Islamabad, Fedral, Pakistan, 44000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: gaze stabilization exercises group
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.
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patients will perform gaze stabilization exercise, Static neck exercise, and Habituation exercise.
Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.
|
|
Active Comparator: control group
Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
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Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Romberg Test
Time Frame: 9 months
|
The Romberg test is a test that measures your sense of balance.
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9 months
|
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Dizziness Handicap Inventory
Time Frame: 9 months
|
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.
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9 months
|
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Vestibular Disorders Activities of Daily Living Scale
Time Frame: 9 months
|
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:
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9 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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