VertigoNCT06637566
Effects of Brandt Daroff Exercises in Older Adults With Vertigo
A study testing Brandt Daroff exercises along with Cawthorne Cooksey exercises and Brandt Daroff exercises in people with Vertigo, run by Riphah International University at 1 site in Pakistan.
Trial summary
Vertigo is among the most prevalent disorder in older adults around the world leads to dizziness and balance problems resulting in decreased quality of life. Brandt daroff exercises can accelerate vertigo recovery and prevent recurrence without taking drugs. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Vertigo
- What is being tested?
- Brandt Daroff exercises along with Cawthorne Cooksey exercises and Brandt Daroff exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Oct 2024to 3 Jan 2025
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults 65or above.
- Both Male and Female.
- Symptoms suggested vertigo, confirmed by neurologist.
- Accepted to participate in study.
- DHI Scale: 36-42 (moderate handicap).
Who cannot join
- Patients having balance issues other than dizziness and vertigo.
- Middle or external ear diseases.
- Cerebrovascular diseases.
- Feet injuries including severe bruises, ulcers, open wounds or recent burns.
- Neck pain and cervical spine disease.
- History of serious musculoskeletal disease (arthritis, Alzheimer's disease, intervertebral disc degeneration).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
DHQ Hospital Joharabad
Jauharabad, Punjab Province, 41200
Syeda Aleena Bukhari, MS-NMPT*
About this study
Official title: Effects Of Brandt Daroff Exercises With Cawthorne Cooksey Exercises On Balance, Dizziness And Functional Parameters In Older Adults With Vertigo
Vertigo is among the most prevalent disorder in older adults around the world leads to dizziness and balance problems resulting in decreased quality of life. Brandt daroff exercises can accelerate vertigo recovery and prevent recurrence without taking drugs. Cawthorne Cooksey first presented vestibular exercises to improve neurophysiological habituation, improves balance in the elderly. This study aims to determine the effects of brandt daroff exercises with cawthorne cooksey exercises on balance, dizziness and functional parameters in older adults with vertigo.
Read the detailed description
This is a randomized controlled trial. Participants will be selected by non-probability convenience sampling technique, thirty two vertigo patients meeting the inclusion criteria will be randomly allocated into two equal groups (experimental and control) by online randomizer tool. The experimental group will receive brandt daroff exercises with cawthorne cooksey exercises and the control group will receive brandt daroff exercises alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. The following assessment tool will be used Visual Analogue Scale and Dizziness Handicap Inventory for vertigo symptom severity, Berg Balance scale and Tinetti POMA for assessment of balance, Functional Independence Measure and IADL Tool for assessment of functional parameters. Assessment will be done at baseline and after 6 week. The data will be analyzed using SPPS software version. 25.
- Conditions
- Vertigo
- Being tested
- Brandt Daroff exercises along with Cawthorne Cooksey exercises, Brandt Daroff exercises
- Keywords
- Vertigo,, balance, functional parameters, dizziness,
- Medical subject headings
- Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brandt Daroff exercises along with Cawthorne Cooksey exercisesOther
Brandt Daroff exercises along with Cawthorne Cooksey exercises. The Cawthorne Cooksey exercises include eye and head movements, coordination of eye and head movements (visual-vestibular interaction), postural control exercises, and progressively more difficult balance tasks (eyes open, eyes closed, large base support, uneven base support, while walking, in high visual or noisy environments). Exercises should be done three times a day, with 5 repetitions of each. The exercises will be performed in three sessions per week with 60 minutes each session for eight weeks. The cawthorne Cooksey exercises includes the following:
A: Eye and head movement
B: Head and body movement, sitting down:
C: Standing up exercises:
Brandt Daroff exercisesOther
brandt daroff exercises without cawthorne Cooksey exercises. To begin the Brandt-daroff exercise, the patient will sit and swivel the head 45 degrees to one side (left), then instantly lie down on the other shoulder (right). The patient should be instructed to maintain this posture for 30 seconds or until the vertigo subsides. The patient then gradually returns to the starting position, maintaining the left ear rotation until sat upright. Following the same 30 second time limits, the patient turns his head in the opposite way (right) and rests down on the opposite shoulder (left). These exercises will be instructed to perform at home for 3 sets (morning, afternoon and evening) with 5 repetitions approximately for 30 minutes in each session for five weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | They receive brandt daroff exercises with cawthorne cooksey exercises. Receives: Other: Brandt Daroff exercises along with Cawthorne Cooksey exercises |
| Control Group | Other | They receive brandt daroff exercises only. Receives: Other: Brandt Daroff exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory:
Dizziness Handicap Inventory (DHI) Scale is used for assessment of dizziness. DHI is 25-item self-report questionnaire that measures the impact of dizziness on a person's daily life and use as screening as well as outcome measuring tool in vertigo patients. Each item on the DHI is scored on a 0 to 4 scale, with 0 meaning "no problem" and 4 meaning "severe problem." It is a widely used tool in clinical practice to assess the severity of dizziness and its effect on a person's functional, emotional, and physical well-being. DHI has been found to have 75% sensitivity. The DHI Scale has been found to have high test-retest reliability (icc0.92) and moderate construct validity (Pearson's correlation coefficient 0.47). It is a self-report questionnaire so no special equipment is required to perform it.
Measured: 6 weeks
Tinetti Performance Oriented Mobolity Assessment
Tinneti POMA (performance oriented mobility assessment) is a reliable tool use for assessment of balance and gait in older adults. The test and retest values for the POMA-T, POMA-B, POMA-G all varied between (0.72) and (0.86). The inter-rater reliability values all varied between (0.80) and (0.93). This test has a sensitivity of 70% and a specificity of 52%. It is a 17-item test that takes about 15 minutes to complete. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totaling 28.
Equipment Required: A hard armless chair, A stopwatch, A 15 feet even and uniform walkway.
Measured: 6 weeks
Lawton Instrumental Activities of Daily Living (IADL) Scale
The Lawton Instrumental Activities of Daily Living (IADL) Scale is used to evaluate independent living skills. The instrument is most useful for identifying how a person is functioning and identifying improvement or deterioration over time. The scale measures eight domains of function including food preparation, housekeeping, laundering. Individuals are scored according to their highest level of functioning in that category.
A summary score ranges from 0(low function, dependent) to 8(high function, independent). Inter-rater reliability was established at.85. Administration time is10-15 minutes
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 posted15 Oct 2024
- Study start8 Oct 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion3 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637566
- Sponsor's protocol ID
- REC/RCR & AHS/24/0207
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teixido M, Casserly R, Melley LE. Lateral Modified Brandt-Daroff Exercises: A Novel Home Treatment Technique for Horizontal Canal BPPV. J Int Adv Otol. 2021 Jan;17(1):52-57. doi: 10.5152/iao.2020.9452.
PubMed 33605222Zamyslowska-Szmytke E, Politanski P, Jozefowicz-Korczynska M. Dizziness Handicap Inventory in Clinical Evaluation of Dizzy Patients. Int J Environ Res Public Health. 2021 Feb 24;18(5):2210. doi: 10.3390/ijerph18052210.
PubMed 33668099
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Brandt Daroff Exercises With Cawthorne Cooksey Exercises On Balance, Dizziness And Functional Parameters In Older Adults With Vertigo
- ClinicalTrials.gov ID
- NCT06637566
- Acronym / sponsor ID
- REC/RCR & AHS/24/0207
- Conditions
- Vertigo
- Keywords
- Vertigo,, balance, functional parameters, dizziness,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 3 Jan 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Vertigo is among the most prevalent disorder in older adults around the world leads to dizziness and balance problems resulting in decreased quality of life. Brandt daroff exercises can accelerate vertigo recovery and prevent recurrence without taking drugs. Cawthorne Cooksey first presented vestibular exercises to improve neurophysiological habituation, improves balance in the elderly. This study aims to determine the effects of brandt daroff exercises with cawthorne cooksey exercises on balance, dizziness and functional parameters in older adults with vertigo.
Detailed description
This is a randomized controlled trial. Participants will be selected by non-probability convenience sampling technique, thirty two vertigo patients meeting the inclusion criteria will be randomly allocated into two equal groups (experimental and control) by online randomizer tool. The experimental group will receive brandt daroff exercises with cawthorne cooksey exercises and the control group will receive brandt daroff exercises alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. The following assessment tool will be used Visual Analogue Scale and Dizziness Handicap Inventory for vertigo symptom severity, Berg Balance scale and Tinetti POMA for assessment of balance, Functional Independence Measure and IADL Tool for assessment of functional parameters. Assessment will be done at baseline and after 6 week. The data will be analyzed using SPPS software version. 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Brandt Daroff exercises along with Cawthorne Cooksey exercisesThey receive brandt daroff exercises with cawthorne cooksey exercises. |
| Control Group | Other | Other: Brandt Daroff exercisesThey receive brandt daroff exercises only. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Older adults 65or above.
- Both Male and Female.
- Symptoms suggested vertigo, confirmed by neurologist.
- Accepted to participate in study.
- DHI Scale: 36-42 (moderate handicap).
Key exclusion criteria (6 listed)
- Patients having balance issues other than dizziness and vertigo.
- Middle or external ear diseases.
- Cerebrovascular diseases.
- Feet injuries including severe bruises, ulcers, open wounds or recent burns.
- Neck pain and cervical spine disease.
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 |
|---|---|---|
| Brandt Daroff exercises along with Cawthorne Cooksey exercisesBrandt Daroff exercises along with Cawthorne Cooksey exercises. The Cawthorne Cooksey exercises include eye and head movements, coordination of eye and head movements (visual-vestibular interaction), postural control exercises, and progressively more difficult balance tasks (eyes open, eyes closed, large base support, uneven base support, while walking, in high visual or noisy environments). Exercises should be done three times a day, with 5 repetitions of each. The exercises will be performed in three sessions per week with 60 minutes each session for eight weeks. The cawthorne Cooksey exercises includes the following: A: Eye and head movement B: Head and body movement, sitting down: C: Standing up exercises: | Other | Experimental Group |
| Brandt Daroff exercisesbrandt daroff exercises without cawthorne Cooksey exercises. To begin the Brandt-daroff exercise, the patient will sit and swivel the head 45 degrees to one side (left), then instantly lie down on the other shoulder (right). The patient should be instructed to maintain this posture for 30 seconds or until the vertigo subsides. The patient then gradually returns to the starting position, maintaining the left ear rotation until sat upright. Following the same 30 second time limits, the patient turns his head in the opposite way (right) and rests down on the opposite shoulder (left). These exercises will be instructed to perform at home for 3 sets (morning, afternoon and evening) with 5 repetitions approximately for 30 minutes in each session for five weeks | Other | Control Group |
Primary outcome
Dizziness Handicap Inventory:
Time frame: 6 weeks
Dizziness Handicap Inventory (DHI) Scale is used for assessment of dizziness. DHI is 25-item self-report questionnaire that measures the impact of dizziness on a person's daily life and use as screening as well as outcome measuring tool in vertigo patients. Each item on the DHI is scored on a 0 to 4 scale, with 0 meaning "no problem" and 4 meaning "severe problem." It is a widely used tool in clinical practice to assess the severity of dizziness and its effect on a person's functional, emotional, and physical well-being. DHI has been found to have 75% sensitivity. The DHI Scale has been found to have high test-retest reliability (icc0.92) and moderate construct validity (Pearson's correlation coefficient 0.47). It is a self-report questionnaire so no special equipment is required to perform it.
Tinetti Performance Oriented Mobolity Assessment
Time frame: 6 weeks
Tinneti POMA (performance oriented mobility assessment) is a reliable tool use for assessment of balance and gait in older adults. The test and retest values for the POMA-T, POMA-B, POMA-G all varied between (0.72) and (0.86). The inter-rater reliability values all varied between (0.80) and (0.93). This test has a sensitivity of 70% and a specificity of 52%. It is a 17-item test that takes about 15 minutes to complete. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totaling 28. Equipment Required: A hard armless chair, A stopwatch, A 15 feet even and uniform walkway.
Lawton Instrumental Activities of Daily Living (IADL) Scale
Time frame: 6 weeks
The Lawton Instrumental Activities of Daily Living (IADL) Scale is used to evaluate independent living skills. The instrument is most useful for identifying how a person is functioning and identifying improvement or deterioration over time. The scale measures eight domains of function including food preparation, housekeeping, laundering. Individuals are scored according to their highest level of functioning in that category. A summary score ranges from 0(low function, dependent) to 8(high function, independent). Inter-rater reliability was established at.85. Administration time is10-15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 33605222Teixido M, Casserly R, Melley LE. Lateral Modified Brandt-Daroff Exercises: A Novel Home Treatment Technique for Horizontal Canal BPPV. J Int Adv Otol. 2021 Jan;17(1):52-57. doi: 10.5152/iao.2020.9452.
- Background: PubMed 33668099Zamyslowska-Szmytke E, Politanski P, Jozefowicz-Korczynska M. Dizziness Handicap Inventory in Clinical Evaluation of Dizzy Patients. Int J Environ Res Public Health. 2021 Feb 24;18(5):2210. doi: 10.3390/ijerph18052210.
- Individual participant dataSharing planned: No
Related trials for Vertigo
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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.
Muhammad Asrar Yousaf, Mphil 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 Brandt Daroff exercises along with Cawthorne Cooksey exercises and Brandt Daroff exercises in people with Vertigo, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory: (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 NCT06637566, which also lists 2 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 15 Oct 2024.