- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06637566
Effects of Brandt Daroff Exercises in Older Adults With Vertigo
Effects Of Brandt Daroff Exercises With Cawthorne Cooksey Exercises On Balance, Dizziness And Functional Parameters In Older Adults With Vertigo
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Joharabad, Punjab, Pakistan, 41200
- DHQ Hospital Joharabad
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Principal Investigator:
- Syeda Aleena Bukhari, MS-NMPT*
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Experimental Group
They receive brandt daroff exercises with cawthorne cooksey exercises.
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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: |
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Other: Control Group
They receive brandt daroff exercises only.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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6 weeks
|
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Tinetti Performance Oriented Mobolity Assessment
Time Frame: 6 weeks
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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. |
6 weeks
|
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Lawton Instrumental Activities of Daily Living (IADL) Scale
Time Frame: 6 weeks
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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 |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Asrar Yousaf, Mphil, Riphah International University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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