Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness
Primary Purpose
Chronic Dizziness
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gaze Stabilization Exercises
Balance Training
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Dizziness
Eligibility Criteria
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
Sites / Locations
- Univeristy Of Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gaze Group
Control Group
Arm Description
Participants performed balance training with gaze stabilization exercises
Participants performed balance training with saccade eye exercises
Outcomes
Primary Outcome Measures
Berg Balance Scale
Balance was measured using Berg Balance Scale
Disability Handicapped Inventory
Precieved Disability was measured using Disability Handicapped Invertory
Activity Specific Balance Confidence
Risk of Fall Prevention was measured using Activity Specific Balance Confidence
Secondary Outcome Measures
Full Information
NCT ID
NCT04751006
First Posted
February 10, 2021
Last Updated
February 10, 2021
Sponsor
University of Lahore
1. Study Identification
Unique Protocol Identification Number
NCT04751006
Brief Title
Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness
Official Title
Effects of Balance Exercise With or Without Gaze Stabilization Exercises on Clinical Outcomes in Elderly Patients With Chronic Dizziness:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
December 5, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore
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
Effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: A Randomized Controlled Trial
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Dizziness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gaze Group
Arm Type
Experimental
Arm Description
Participants performed balance training with gaze stabilization exercises
Arm Title
Control Group
Arm Type
Other
Arm Description
Participants performed balance training with saccade eye exercises
Intervention Type
Other
Intervention Name(s)
Gaze Stabilization Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Balance was measured using Berg Balance Scale
Time Frame
6 Weeks
Title
Disability Handicapped Inventory
Description
Precieved Disability was measured using Disability Handicapped Invertory
Time Frame
6 Weeks
Title
Activity Specific Balance Confidence
Description
Risk of Fall Prevention was measured using Activity Specific Balance Confidence
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syeda Nida Fatima
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy Of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
5400
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Results of study
Citations:
PubMed Identifier
28483885
Citation
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.
Results Reference
background
PubMed Identifier
20588090
Citation
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.
Results Reference
background
PubMed Identifier
30947233
Citation
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.
Results Reference
background
PubMed Identifier
22419420
Citation
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. doi: 10.1142/S0192415X1250019X.
Results Reference
result
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Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness
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