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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Imran Amjad, Phd contact

03324390125

Imran.amjad@riphah.edu.pk

Pakistan1 site
  • DHQ Hospital Joharabad

    Jauharabad, Punjab Province, 41200

    Syeda Aleena Bukhari, MS-NMPT*

Other trials in Pakistan

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 groups in NCT06637566
Study groupRoleWhat they receive
Experimental GroupActive comparatorThey receive brandt daroff exercises with cawthorne cooksey exercises.
Receives: Other: Brandt Daroff exercises along with Cawthorne Cooksey exercises
Control GroupOtherThey 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.

  1. 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

  2. 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

  3. 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.

  1. First posted15 Oct 2024
  2. Study start8 Oct 2024 (estimated)
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion3 Jan 2025 (estimated)

Resources

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)
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 33605222
  • Zamyslowska-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

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.

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