VertigoNCT06760975
Effects of Vestibular Habituation and Ocular Reflex Exercises on Vertigo
A study testing Vestibular Habituation Exercises and Ocular Reflex Excercises in people with Vertigo, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Vertigo
- What is being tested?
- Vestibular Habituation Exercises and Ocular Reflex Excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPakistan
- Study dates
- 31 Dec 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Both male and female patients
- Age 65-75
- patient with vestibular disorder for at least 6 months
- patient with unspecific dizziness sensation for at least 3 months
- Dizziness handicap inventory score > 16 -
Who cannot join
- patient with central nervous system diseases, like stroke, multiple sclerosis, Parkinson's disease.
- orthopedic problems that precluded performance of the exercises
- systemic diseases with no medication control
- if patient were legally blind or had dementia
- patient with no history of epilepsy and other neurological diseases -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Rasheed Hospital Lahore
Lahore, Punjab Province
Services Hospital Lahore
Lahore, Punjab Province
About this study
Official title: Comparative Effects of Vestibular Habituation and Ocular Reflex Exercises on Gait Stability, Dizziness Severity, and Fear of Fall in Elderly Population With Vertigo
The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo
Read the detailed description
vestibular habituation exercises focus on helping individual adapt to and reduce symptoms related to vestibular disorder such as improving balance , reducing dizziness and enhance overall functional abilities. ocular reflex exercises focus on improving eye movement control and coordination such as improving visual tracking , stability and Focus. This randomized clinical trial will be conducted at services hospital and Jinnah hospital for a duration of 10 months. The sample size will consist of 50 participants. 25 participants will be assigned to vestibular habituation exercise group and 25 to ocular reflex exercises group. Data will be collected using these assessment tools, including the dynamic gait index for gait stability, the fall efficacy scale for fear of fall, and dizziness handicap inventory for dizziness severity. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured at baseline ,in the 3rd week ,post intervention, after 6 weeks, and at a 9th week follow up. Data analysis will be performed by using SPSS 26 software
- Conditions
- Vertigo
- Being tested
- Vestibular Habituation Exercises, Ocular Reflex Excercises
- Keywords
- vertigo, Habituation, Ocular reflex, Fear of fall, Gait stability
- Medical subject headings
- Vertigo, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Habituation ExercisesOther
The vestibular habituation exercise group follows a structured progression over six weeks. in week 1 participants perform large amplitude, rapid cervical rotations seated, completing 3 sets of five cycles each. By week 2, the exercises increase in complexity , incorporates standing pivots or seated trunk flexion extension. in week 3 the cervical rotations are continued with seated or standing posture. week 4 introduces a busy visual background during the exercise to challenge visual-vestibular integration. In week 5 the exercises are performed standing with the addition complex visual target against a busy background. finally week 6 includes most advance movement including standing pivots 180 degrees and brand-daroff exercises with further visual challenges of near and far targets in busy background. Each exercise session last for 2 minutes and is aimed at progressively enhancing vestibular processing and adaptability.
Ocular Reflex ExcercisesOther
The Ocular reflex exercises focuses on enhancing visual tracking and reflexes through targeted viewing exercises. In week 1, participants perform horizontal and vertical X1 viewing exercises with a near target, holding each position for 1 minute while seated. In week 2 the duration of the X1 exercises is extended to 2 minutes with the near target still in seated position. Week 3 shift to a far target for the X1 exercises and the participants performs them while standing increasing the challenge. By week 4 the exercise incorporate both near and far target in front of a busy background. extending the duration to 2 minutes while standing. In week 5 horizontal and vertical X2 viewing exercises are added with a plain background, while still using near and far targets in front of a busy background . finally week 6 continues the X1 and X2 exercises with near and far targets in a busy background, performed for 2 minutes while standing. This aims to improve visual tracking.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A Vestibular Habituation Exercises | Experimental | Group A will receive 24 sessions of vestibular habituation exercises, delivered 4 times weekly for six weeks, each session lasting 30 minutes. Effects will be measured at baseline, in the 3rd week, post-intervention, after six weeks, and at a 9th-week follow-up. Receives: Other: Vestibular Habituation Exercises |
| GROUP B Ocular Reflex exercises | Experimental | Group B will receive ocular reflex exercises. A total of 24 sessions (4x/week for 6 weeks) will be conducted , lasting 50-60 minutes each. The effects will be measured at baseline, in the 3rd week, post intervention, after six weeks, and at a 9th-week follow-up. Receives: Other: Ocular Reflex Excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic gait index
The DGI is used for gait assessment and has 8 items. The scoring of DGI is based on 4 point scale ranging from 0-3 while 0 indicates severe impairment and 3 indicates normal ability. DGI proves to be reliable and valid for older people. Total score for best performance is 24 and low score on DGI indicates greater impairment in functional mobility.
Measured: 6 weeks
FES-I Fall efficacy scale international
FES-I scale is used to access fear of fall and is consist of 16 items questionnaire allows participants to rate their fear of falling during specific activities at the rate of four different intensities ranging from "not at all concerned to vary concerned". Higher scores indicates a more significant fear of falling. score range from 16-19 show low concern of falling. Score ranges from 20-27 shows moderate concern and score ranges from 28-64 show high concern of fall to daily Activities.
Measured: 6 weeks
Dizziness Handicap inventory
The DHI is used to access dizziness and is consist of 25 items. Each item is answered with No (0) points sometimes (2) points or Yes (4) points. Scoring of DHI ranges from 0 to 100. further divided into physical (28) points , functional (36) points and emotional (36) points. The higher the scores result in perceived handicap. Moreover (DHI) proved to be a reliable instument
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, MS-NMPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760975
- Sponsor's protocol ID
- REC/RCR&AHS/24/0255
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayat A, Pourbakht A, Saki N, Zainun Z, Nikakhlagh S, Mirmomeni G. Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Iran Red Crescent Med J. 2012 Nov;14(11):705-8. doi: 10.5812/ircmj.3507. Epub 2012 Nov 15.
PubMed 23396380Balatsouras DG, Koukoutsis G, Fassolis A, Moukos A, Apris A. Benign paroxysmal positional vertigo in the elderly: current insights. Clin Interv Aging. 2018 Nov 5;13:2251-2266. doi: 10.2147/CIA.S144134. eCollection 2018.
PubMed 30464434Cohen HS, Kimball KT. Increased independence and decreased vertigo after vestibular rehabilitation. Otolaryngol Head Neck Surg. 2003 Jan;128(1):60-70. doi: 10.1067/mhn.2003.23.
PubMed 12574761Hall 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.
PubMed 20588090Norre ME, Beckers A. Vestibular habituation training: exercise treatment for vertigo based upon the habituation effect. Otolaryngol Head Neck Surg. 1989 Jul;101(1):14-9. doi: 10.1177/019459988910100104.
PubMed 2502758Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
PubMed 19629221
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Vestibular Habituation and Ocular Reflex Exercises on Gait Stability, Dizziness Severity, and Fear of Fall in Elderly Population With Vertigo
- ClinicalTrials.gov ID
- NCT06760975
- Acronym / sponsor ID
- REC/RCR&AHS/24/0255
- Conditions
- Vertigo
- Keywords
- vertigo, Habituation, Ocular reflex, Fear of fall, Gait stability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo
Detailed description
vestibular habituation exercises focus on helping individual adapt to and reduce symptoms related to vestibular disorder such as improving balance , reducing dizziness and enhance overall functional abilities. ocular reflex exercises focus on improving eye movement control and coordination such as improving visual tracking , stability and Focus. This randomized clinical trial will be conducted at services hospital and Jinnah hospital for a duration of 10 months. The sample size will consist of 50 participants. 25 participants will be assigned to vestibular habituation exercise group and 25 to ocular reflex exercises group. Data will be collected using these assessment tools, including the dynamic gait index for gait stability, the fall efficacy scale for fear of fall, and dizziness handicap inventory for dizziness severity. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured at baseline ,in the 3rd week ,post intervention, after 6 weeks, and at a 9th week follow up. Data analysis will be performed by using SPSS 26 software
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A Vestibular Habituation Exercises | Experimental | Other: Vestibular Habituation ExercisesGroup A will receive 24 sessions of vestibular habituation exercises, delivered 4 times weekly for six weeks, each session lasting 30 minutes. Effects will be measured at baseline, in the 3rd week, post-intervention, after six weeks, and at a 9th-week follow-up. |
| GROUP B Ocular Reflex exercises | Experimental | Other: Ocular Reflex ExcercisesGroup B will receive ocular reflex exercises. A total of 24 sessions (4x/week for 6 weeks) will be conducted , lasting 50-60 minutes each. The effects will be measured at baseline, in the 3rd week, post intervention, after six weeks, and at a 9th-week follow-up. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Both male and female patients
- Age 65-75
- patient with vestibular disorder for at least 6 months
- patient with unspecific dizziness sensation for at least 3 months
- Dizziness handicap inventory score > 16 -
Key exclusion criteria (5 listed)
- patient with central nervous system diseases, like stroke, multiple sclerosis, Parkinson's disease.
- orthopedic problems that precluded performance of the exercises
- systemic diseases with no medication control
- if patient were legally blind or had dementia
- patient with no history of epilepsy and other neurological diseases -
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 |
|---|---|---|
| Vestibular Habituation ExercisesThe vestibular habituation exercise group follows a structured progression over six weeks. in week 1 participants perform large amplitude, rapid cervical rotations seated, completing 3 sets of five cycles each. By week 2, the exercises increase in complexity , incorporates standing pivots or seated trunk flexion extension. in week 3 the cervical rotations are continued with seated or standing posture. week 4 introduces a busy visual background during the exercise to challenge visual-vestibular integration. In week 5 the exercises are performed standing with the addition complex visual target against a busy background. finally week 6 includes most advance movement including standing pivots 180 degrees and brand-daroff exercises with further visual challenges of near and far targets in busy background. Each exercise session last for 2 minutes and is aimed at progressively enhancing vestibular processing and adaptability. | Other | GROUP A Vestibular Habituation Exercises |
| Ocular Reflex ExcercisesThe Ocular reflex exercises focuses on enhancing visual tracking and reflexes through targeted viewing exercises. In week 1, participants perform horizontal and vertical X1 viewing exercises with a near target, holding each position for 1 minute while seated. In week 2 the duration of the X1 exercises is extended to 2 minutes with the near target still in seated position. Week 3 shift to a far target for the X1 exercises and the participants performs them while standing increasing the challenge. By week 4 the exercise incorporate both near and far target in front of a busy background. extending the duration to 2 minutes while standing. In week 5 horizontal and vertical X2 viewing exercises are added with a plain background, while still using near and far targets in front of a busy background . finally week 6 continues the X1 and X2 exercises with near and far targets in a busy background, performed for 2 minutes while standing. This aims to improve visual tracking. | Other | GROUP B Ocular Reflex exercises |
Primary outcome
Dynamic gait index
Time frame: 6 weeks
The DGI is used for gait assessment and has 8 items. The scoring of DGI is based on 4 point scale ranging from 0-3 while 0 indicates severe impairment and 3 indicates normal ability. DGI proves to be reliable and valid for older people. Total score for best performance is 24 and low score on DGI indicates greater impairment in functional mobility.
FES-I Fall efficacy scale international
Time frame: 6 weeks
FES-I scale is used to access fear of fall and is consist of 16 items questionnaire allows participants to rate their fear of falling during specific activities at the rate of four different intensities ranging from "not at all concerned to vary concerned". Higher scores indicates a more significant fear of falling. score range from 16-19 show low concern of falling. Score ranges from 20-27 shows moderate concern and score ranges from 28-64 show high concern of fall to daily Activities.
Dizziness Handicap inventory
Time frame: 6 weeks
The DHI is used to access dizziness and is consist of 25 items. Each item is answered with No (0) points sometimes (2) points or Yes (4) points. Scoring of DHI ranges from 0 to 100. further divided into physical (28) points , functional (36) points and emotional (36) points. The higher the scores result in perceived handicap. Moreover (DHI) proved to be a reliable instument
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 23396380Bayat A, Pourbakht A, Saki N, Zainun Z, Nikakhlagh S, Mirmomeni G. Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Iran Red Crescent Med J. 2012 Nov;14(11):705-8. doi: 10.5812/ircmj.3507. Epub 2012 Nov 15.
- Background: PubMed 30464434Balatsouras DG, Koukoutsis G, Fassolis A, Moukos A, Apris A. Benign paroxysmal positional vertigo in the elderly: current insights. Clin Interv Aging. 2018 Nov 5;13:2251-2266. doi: 10.2147/CIA.S144134. eCollection 2018.
- Background: PubMed 12574761Cohen HS, Kimball KT. Increased independence and decreased vertigo after vestibular rehabilitation. Otolaryngol Head Neck Surg. 2003 Jan;128(1):60-70. doi: 10.1067/mhn.2003.23.
- Background: PubMed 20588090Hall 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.
- Background: PubMed 2502758Norre ME, Beckers A. Vestibular habituation training: exercise treatment for vertigo based upon the habituation effect. Otolaryngol Head Neck Surg. 1989 Jul;101(1):14-9. doi: 10.1177/019459988910100104.
- Background: PubMed 19629221Strupp M, Brandt T. Diagnosis and treatment of vertigo and dizziness. Dtsch Arztebl Int. 2008 Mar;105(10):173-80. doi: 10.3238/arztebl.2008.0173. Epub 2008 Mar 7.
- 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.
Hira Jabeen, MS-NMPT study chair
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Habituation Exercises and Ocular Reflex Excercises in people with Vertigo, run by Riphah International University at 2 sites 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen, MS-NMPT (03234116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic gait index (time frame: 6 weeks). 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 NCT06760975, which also lists 6 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 7 Jan 2025.