DizzinessNCT05707130
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients
A study testing gaze stabilization exercises and neck isometrics in people with Dizziness and Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of gaze stabilization exercises on dizziness, balance and quality of life in patients with cervical spondylosis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Dizziness, Balance; Distorted, Cervical Spondylosis
- What is being tested?
- gaze stabilization exercises and neck isometrics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with cervical radiculopathy
- Any drug allergy and neurological deficits were excluded from the study.
- Dizziness due to ear infection and due to BPPV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Patients With Cervical Spondylosis.
To determine the effects of gaze stabilization exercises on dizziness, balance and quality of life in patients with cervical spondylosis.
Read the 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.
- Conditions
- Dizziness, Balance; Distorted, Cervical Spondylosis
- Being tested
- gaze stabilization exercises, neck isometrics
- Keywords
- Dizziness, Balance; Distorted, Cervical Spondylosis
- Medical subject headings
- Dizziness, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaze stabilization exercisesOther
patients will perform gaze stabilization exercise, Static neck exercise, and Habituation exercise. Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.
neck isometricsOther
Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: gaze stabilization exercises |
| control group | Active comparator | Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending. Receives: Other: neck isometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Romberg Test
The Romberg test is a test that measures your sense of balance.
Measured: 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.
Measured: 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:
- 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest Hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707130
- Sponsor's protocol ID
- REC/RCR & AHS/22/0218
- Status last verified
- Mar 2023
- First submitted
- 23 Jan 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29768345Reddy 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.
PubMed 31615495Meng 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.
PubMed 28667278Lv 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.
PubMed 30205836
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Patients With Cervical Spondylosis.
- ClinicalTrials.gov ID
- NCT05707130
- Acronym / sponsor ID
- REC/RCR & AHS/22/0218
- Conditions
- Dizziness, Balance; Distorted, Cervical Spondylosis
- Keywords
- Dizziness, Balance; Distorted, Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| gaze stabilization exercises group | Experimental | Other: gaze stabilization exercisesExperimental 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. |
| control group | Active comparator | Other: neck isometricsPatients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with cervical radiculopathy
- Any drug allergy and neurological deficits were excluded from the study.
- Dizziness due to ear infection and due to BPPV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gaze stabilization exercisespatients will perform 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 group |
| neck isometricsPatients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending. | Other | control group |
Primary outcome
Romberg Test
Time frame: 9 months
The Romberg test is a test that measures your sense of balance.
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.
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: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 29768345Sun 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.
- Background: PubMed 31615495Reddy 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.
- Background: PubMed 28667278Meng 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.
- Background: PubMed 30205836Lv 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeest Hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaze stabilization exercises and neck isometrics in people with Dizziness and Balance; Distorted, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Romberg Test (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707130, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.