- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751006
Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness
February 10, 2021 updated by: University of Lahore
Effects of Balance Exercise With or Without Gaze Stabilization Exercises on Clinical Outcomes in Elderly Patients With Chronic Dizziness:A Randomized Controlled Trial
Effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: A Randomized Controlled Trial
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In older adults dizziness is a common condition which is associated with repeated falls, fear of falling, depression, anxiety and ultimately loss of independence during activities of daily living.
The main objective of this research was to compare the effects of balance training with and without Gaze Stabilization exercises on clinical outcomes in elderly patient with chronic dizziness.Total 64 participants after referral from neurologist were recruited in this study.
These participants were randomly assigned into two groups i.e.
Group A (Gaze group) and Group B (control group) with 32 participants in each group by sealed envelope method.
Gaze group performed balance exercises with gaze stability exercises.
Gaze stability exercises are further classified as adaptation and substitution exercises.
Adaptation exercises support long term changes with a purpose of decreasing symptoms and maintain postural stability.
On the other hand the substitution exercises improving central preprogrammed movement of eyes.
Basically gaze stability exercises are defined as habituation exercises which reduce the symptoms of provoking stimulus by continuous exposure to it whereas, group B performed balance exercises with saccade eye exercises.Balance training includes both static and dynamic balance exercises, aimed to improved balance and postural stability with gradually increasing to challenging task.
Exercises in balance training included a) single leg balance on firm surface b) heel stand c) marching on firm surface d) toe stand e) tandem walk f) forward and backward walking from normal base of support to weekly progression and training from eyes open to eye close from stable to unstable surface.
Berg Balance Scale, Disability Handicapped inventory and Activity Specific Balance Confidence Scale were used to measure outcome variables.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 5400
- Univeristy Of Lahore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Geriatric population
- Both Gender
- H/O chronic dizziness with normal vestibular function
- H/O age related balance impairment
- H/O impaired balance having a Berg Balance Scale (BBS) score between 35-45
- Participant have sufficient cognitive and communication skills
Exclusion Criteria:
- H/O insufficient communication skills to follow instructions
- H/O impaired vestibular function
- H/O Visual impairment
- H/O Severe hearing loss
- H/O mental disorder that could restrains the ability to concentrate during therapy
- H/O Other systematic diseases
- Any history of marked musculoskeletal impairment, lower limb injury, surgery other than age related changes and balance disorder due to other neurological conditions like Parkinsonism, stroke, multiple sclerosis etc. were excluded from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gaze Group
Participants performed balance training with gaze stabilization exercises
|
Gaze group performed balance exercises with gaze stability exercise.Gaze stability exercises included two types of exercises vestibular adaptation and substitution exercises.
In Adaptation exercises individual need to fixate on a visual target during horizontal and vertical head movement with a purpose of increasing gaze stability and a long term gain to vestibular system.
Subsitution exercises are planned to use other eye movement stratigies to substitute vestibular function and sustained visual fixation.
During Substitution exercises individual need to perfomed eye head movement between target with a purpose of clear sighting during these tasks.
Balance exercises consist of both static and dynamic balance exercises with weekly progression making balance exercises more challenging.
|
|
Other: Control Group
Participants performed balance training with saccade eye exercises
|
Participants performed balance training with saccade eye exercises.balance
exercises included both static and dynamic balance exercises with a purpose of increasing mobility and stability of a posture by weekly progression.
These exercises included standing on firm and foam surface with eyes open or close, heel stand, toe stand, marching on firm surface, forward and backward walking with normal base of support with weekly progression.
Each task was performed for 5 repetitions with weekly progression in each task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 6 Weeks
|
Balance was measured using Berg Balance Scale
|
6 Weeks
|
|
Disability Handicapped Inventory
Time Frame: 6 Weeks
|
Precieved Disability was measured using Disability Handicapped Invertory
|
6 Weeks
|
|
Activity Specific Balance Confidence
Time Frame: 6 Weeks
|
Risk of Fall Prevention was measured using Activity Specific Balance Confidence
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Syeda Nida Fatima, University of Lahore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Geraghty AWA, Essery R, Kirby S, Stuart B, Turner D, Little P, Bronstein A, Andersson G, Carlbring P, Yardley L. Internet-Based Vestibular Rehabilitation for Older Adults With Chronic Dizziness: A Randomized Controlled Trial in Primary Care. Ann Fam Med. 2017 May;15(3):209-216. doi: 10.1370/afm.2070.
- Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
- Jahn K. The Aging Vestibular System: Dizziness and Imbalance in the Elderly. Adv Otorhinolaryngol. 2019;82:143-149. doi: 10.1159/000490283. Epub 2019 Jan 15. Review.
- Maciaszek J, Osinski W. Effect of Tai Chi on body balance: randomized controlled trial in elderly men with dizziness. Am J Chin Med. 2012;40(2):245-53.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2020
Primary Completion (Actual)
December 5, 2020
Study Completion (Actual)
December 8, 2020
Study Registration Dates
First Submitted
February 10, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 11, 2021
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/718-XII/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Results of study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Chronic Dizziness
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Mayo ClinicRecruitingChronic Dizziness | Persistent Postural Perceptual DizzinessUnited States
-
Boston Children's HospitalNot yet recruitingVestibular Migraine | Chronic Dizziness | Persistent Postural Perceptual DizzinessUnited States
-
Assiut UniversityNot yet recruiting
-
Hospital Clinico Universitario de SantiagoInstituto de Salud Carlos III; European Regional Development FundUnknownFall | Dizziness ChronicSpain
-
Korea Health Industry Development InstituteTerminatedChronic Subjective DizzinessKorea, Republic of
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonCompletedVestibular Disease | Chronic Dizziness | Persistent Postural Perceptual DizzinessUnited Kingdom
-
Hospital Clinico Universitario de SantiagoInstituto de Salud Carlos III; European Regional Development FundCompletedFall | Elderly | Dizziness Chronic
-
Nagoya City UniversityCompletedChronic DizzinessJapan
-
Guy's and St Thomas' NHS Foundation TrustWithdrawnVestibular Disease | Chronic DizzinessUnited Kingdom
-
Mayo ClinicCompletedDizziness ChronicUnited States
Clinical Trials on Gaze Stabilization Exercises
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University of FaisalabadActive, not recruitingVestibular Diseases | Motion Sickness | CybersicknessPakistan
-
Emory UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedVestibular Schwannoma | Vestibular Neuronitis | Vestibular Neuronitis, BilateralUnited States
-
Inonu UniversityCompletedVertigo, Peripheral | Vestibular DiseaseTurkey
-
George Washington UniversityTerminatedVestibular DisorderUnited States
-
Riphah International UniversityCompletedDizziness | Cervical Spondylosis | Balance; DistortedPakistan
-
Foundation University IslamabadCompletedNystagmus | Optokinetic NystagmusPakistan
-
National Yang Ming Chiao Tung UniversityNot yet recruiting
-
Riphah International UniversityRecruitingQuality of Life | Gait, Hemiplegic | Balance; DistortedPakistan
-
King Saud UniversityRecruitingMigraine | Vertigo | Vertigo, Peripheral | Vertigo LabyrinthineSaudi Arabia
-
Riphah International UniversityCompletedHEARING IMPAIRED CHILDRENPakistan